Prevent CRA Fraud: 5 Strategies to Protect Your CRO Team

If you haven’t heard the story of TAK Flight 363, pay attention — it might save you hundreds of thousands of dollars or more on your next clinical research study by protecting you against CRA fraud.

But how is an airline flight relevant to clinical research or CRA fraud, you ask?

As it turns out, in more ways than you might think.

You see, Flight 363 was a passenger airliner that found itself attempting to land at Kazan International Airport in Russia, on November 17, 2013.

Sadly, the jetliner crashed, and all passengers and crew on board lost their lives.

The investigation into the crash revealed that the captain of the flight had obtained his pilot's license using falsified documents. He had not completed the required training and had significantly overstated his flying experience.

The tragic story of Flight 363 underscores the grave consequences that can result when an organization fails to properly vet the qualifications and integrity of its employees.

While the pilot's fraudulent actions are reprehensible, the airline's hiring process allowed an unqualified pilot with critical skill gaps to slip through the cracks.

With devastating results.

As a clinical research employer or hiring manager, this cautionary tale serves as a reminder to closely examine your own hiring practices and ensure that you have the necessary safeguards in place to prevent unqualified people from joining your clinical research team.

This CCRPS guide helps you identify any vulnerabilities in your hiring process that bad actors could exploit, and gives you the tools and techniques to combat them. Let’s dive in.

Is CRA Fraud Really a Problem You Need to Worry About?

You might be surprised to hear this, but many senior-level professionals in the clinical research industry are somewhat indifferent to the issue of CRA fraud.

The sentiment seems to be: the system still works. If it ain’t broke, don’t fix it, right?

This isn’t an accurate assessment of the risks. The outcomes of bad hires in clinical research may not garner as much media attention as the crash of an airliner, but the stakes can be just as high.

A botched study might lead to an ineffective treatment wrongly progressing to the next stage of development, or an effective one getting delayed or canceled due to sloppy procedures. In both cases, the consequences can sometimes be literally life or death for the people whose lives the treatment affects.

Aside from the potential human costs, the direct monetary costs to your organization are also very real.

Recent data show that even small-scale RCTs can cost more than $200K on the lower range. And depending on who you ask, larger studies for medical device or drug development can cost anywhere from $49 million, or $54 million, to even $375 million per drug or device.

Incidentally, that much money can buy you about 18 airliners of the kind that were involved in the Flight 363 crash. In other words, the fallout of a ruined study can be monetarily even more damaging than writing off a state-of-the-art commercial jet.

The Real Costs of Fake Qualifications

The scenarios above aren’t purely hypothetical. In recent years, there have been many examples of Contract Research Organizations (CROs) and sponsor companies facing the consequences of inadequate CRA hiring and oversight.

In 2016, the FDA issued a warning letter to Semler Research, citing data integrity issues that stemmed from unqualified or inadequately trained clinical research staff, including CRAs. The resulting unreliable study results not only damaged the CRO’s reputation but also impacted the sponsors who had relied on their services.

Similarly, Cetero Research faced significant fallout from data integrity issues arising from poor CRA training and oversight, among other things. In this case, it led to the company’s bankruptcy and forced several sponsors to repeat studies at a cost of millions of dollars.

As these examples illustrate, the costs of hiring unqualified or fraudulent CRAs can be staggering, both in terms of direct financial losses and long-term reputational damage.

Cases of clinical research staffers lacking sufficient or authentic training and experience are also not isolated incidents. Authors of a 2021 study found that more than 12 percent of resumes for positions in health research were fraudulent.

Based on our interactions with dozens of the top employers in the industry, we believe that that number has grown. In 2024, we estimate that the incidence of applications with fraudulent qualifications can be as high as one in every five or six resumes in certain recruitment pools.

Fraud-proofing Your Clinical Hiring Process

As an employer, your responsibility includes ensuring that your hiring process is rigorous enough to identify and weed out candidates who lack the necessary qualifications, experience, or integrity to perform critical roles, whether those are CRAs, research coordinators, or data managers.

But as HR teams everywhere will attest, the prevalence and sophistication of fraud in the hiring process is constantly on the rise.

No sooner do recruiters spot and plug a racket than new ones turn up in a matter of days.

Effective screening means going beyond basic resume reviews and gimmicky portals that claim to solve the problem using simplistic tests and tools.

Here’s how.

1. Go Beyond the Obvious Clinical Role / CRA Red Flags

You already know the usual suspects:  discrepancies in documentation and employment history, vague answers to technical questions, and a lack of any verifiable digital footprint.

Push beyond these to uncover other telltale signs of an unqualified or under-qualified candidates, including:

Misunderstanding of Niche Skills

Candidates presenting a generic understanding of CRA or CRO functions, but lacking specific knowledge in the therapeutic area they claim expertise in. For example, claiming to be an oncology CRA but unable to explain common trial endpoints and standard-of-care treatments.

For instance, we came across a CRO manager who mentioned a CRA who kept referencing a “one five seven two form,” instead of the industry-standard “fifteen seventy-two” terminology. By itself, a single cue like this means nothing, but a lot of these subtle signs can add up — don’t ignore them.

Over-emphasis on Speed

Candidates may focus heavily on metrics of speed over quality. For example, boasting about high patient recruitment numbers without being able to discuss retention or data quality strategies. This may suggest a willingness to take shortcuts for the sake of appearances.

Cookie-Cutter Answers

Providing overly polished and rehearsed answers in interviews, particularly for scenario-based questions. This may indicate memorization rather than genuine problem-solving skills or an ability to adapt to unique trial complexities.

New AI tools can help you rapidly generate expert-level questions and answers, so that you don’t have to confine yourself to a limited bank of overused interview questions.

2. Use Multi-modal Interviews

Combine traditional in-person or video interviews with asynchronous video assessments, where candidates record their responses to a set of predetermined questions.

This allows you to evaluate a candidate's communication skills, poise, and subject matter expertise in a more controlled setting, while also making it harder for them to receive off-camera assistance.

Platforms like Glider.ai offer features such as facial recognition, eye-tracking to detect shifts in gaze, and audio analysis to flag suspicious noises like typing, whispering, and background voices.

Services like HireRight.com and Ferretly.com can bolster your background verification effort, with features such as AI-powered social media analytics to mitigate the risks of fraud and bad hires.

3. Maintain a List of Suspicious Employers and Institutions

There are actually unscrupulous businesses out there that offer fake employment credentials and even references for a fee. Maintaining a database of companies that consistently turned up on the resumes of disqualified candidates or bad hires will help you improve your process over time.

The same is also true of training institutions. There are dozens of sketchy institutions whose training is of questionable quality and sometimes even entirely nonexistent. (We’ve even come across accounts of self-professed training institutions whose curriculum consists of nothing but PDFs downloaded from the FDA website.) 

These businesses typically attract freshers with the promise of “guaranteed” jobs (a big red-flag for any training institution). Below are just a handful of examples.

Programs with guaranteed job placement

4. Foster a Culture of Openness and Responsibility

While it may seem counterintuitive, creating a culture of fear can actually increase the risk of fraud going undetected.

When individuals feel that they will be severely punished, they go to greater lengths to conceal their deception, using more sophisticated methods and enlisting the help of others to cover their tracks.

Instead, consider fostering a culture of openness and responsibility, where CRAs and other staffers feel safe to admit mistakes, ask for help, and report concerns without fear of retribution.

There are five key elements to achieving this:

i. Establish Clear Reporting Channels

Provide multiple, confidential avenues for CRAs to report any concerns or suspicions of fraudulent activity, such as an anonymous hotline or a designated ombudsman. Make sure these channels are well-publicized and easily accessible.

ii. Encourage Open Communication

Create regular opportunities for CRAs to provide feedback and raise concerns, such as town hall meetings, surveys, or one-on-one check-ins with managers. Actively listen to their input and take appropriate action to address any issues they raise.

iii. Provide Support and Resources

Offer training, mentoring, and other resources to help CRAs succeed in their roles and overcome any challenges they may face. Make it clear that the organization is invested in their success and is willing to provide the support they need to do their jobs with integrity.

iv. Recognize and Reward Ethical Behavior

Publicly acknowledge and celebrate CRAs who demonstrate integrity, honesty, and commitment to quality. Use these individuals as role models and ambassadors for your organization's values.

Remember to address concerns promptly and fairly. When team members report issues or admit mistakes, investigate them promptly and thoroughly, and take appropriate action to address any shortcomings. Be transparent about the process and the outcomes to avoid any perception of retaliation or unfairness.

v. Foster a Sense of Shared Responsibility

Emphasize that maintaining the integrity and reputation of the organization is everyone's responsibility, not just management's. Encourage CRAs to see themselves as partners in the fight against fraud, and to take proactive steps to identify and prevent it.

5. Build Your Own “Talent Pipeline”

While hiring experienced CRAs is ideal, the reality is that the talent market is tight.

Investing in high-quality, targeted training for entry-level recruits can be a strategic solution to combat CRA shortages, accelerate a new hire's proficiency on the job, and improve your organizational outcomes. Here’s how:

Tailored Training

Partnering with established training providers like CCRPS, who specialize in CRA training, allows CROs to quickly onboard new hires with the core theoretical knowledge and practical skills needed.

We’ve worked with dozens of companies in the industry, and our clients consistently report significant performance improvements with new hires who complete our training program.

Address Specific Needs

Even with pre-hire experience, CRAs may have gaps in specific therapeutic areas or familiarity with your CRO's standard operating procedures (SOPs). Customized training can bridge these gaps, leading to faster deployment and better study outcomes.

Improve Cost-Effectiveness

It doesn’t take a mathematician to work out that the costs of training are insignificant compared to the cost of redoing studies or the cost of waiting endlessly to find the scarce "perfect" experienced candidate.

Trained entry-level CRAs reduce internal training burdens, improve project efficiency, and contribute to higher retention rates by fostering growth.

And of course, developing a reputation for investing in entry-level CRAs helps attract top talent in terms of candidates committed to career growth. This positions your organization for success even in a tight labor market.

The Disruptive Future of CRA Fraud Prevention

The current approach to CRA fraud (or fraud in any clinical role, for that matter) is largely reactive, patching vulnerabilities as they surface.

This status quo of reacting to ever-evolving fraud tactics is insufficient. To stay ahead of the curve, CROs and clinical research employers must become disrupters themselves.

I know the article title promised five actionable strategies, but in the typical CCRPS spirit of more is more, here are further ideas for you to consider — if your organization is ready for more advanced measures:

Leveraging Game Theory: Model the decision-making process of fraudsters to understand their vulnerabilities. Can strategic changes in hiring and verification make it less profitable or riskier for them to target CROs?

Data-Driven Prediction: Could tools built on large datasets identify early warning signs of high-risk candidates? Imagine a solution that analyzes transcripts, interviews, reference check patterns, and online footprints to go beyond just existing techniques.

Unconventional Techniques: What if your organization used ideas from outside the clinical research industry? For instance, using “red teaming” methods from cybersecurity can harden your process against fraud, and collaborating with academic researchers specializing in behavioral psychology could yield insights that discourage bad apples.

This isn't a call to embrace these disruptive ideas blindly, but rather a challenge to foster a culture of innovation and calculated risk-taking. CROs who lead the way in transforming the fight against fraud won't just protect themselves, they'll shape the future of a more secure and trustworthy clinical research industry.

Clinical Research vs Lab Research: An In-depth Analysis

Clinical research, a cornerstone in advancing patient care, involves human subjects to test the safety and effectiveness of new treatments, ranging from drugs to diagnostic tools. Unlike clinical research, laboratory research focuses on the foundational science behind medicine without direct human involvement, contributing significantly to medical lab science.

The contrast between clinical research vs lab research highlights the diverse approaches in the scientific pursuit of better healthcare, where every medical advancement once relied on volunteer participation in clinical studies 1. Bridging these two fields promises to accelerate the translation of lab discoveries into practical medical applications, underscoring the importance of collaboration in future developments in medical lab science 1 2.

The Evolution of Clinical Research

The evolution of clinical research traces its origins back to ancient times, with the world's first recorded clinical trial found in the "Book of Daniel" where a dietary intervention was observed to improve health after 10 days. This historical milestone was followed by significant advancements including Avicenna's rules for drug testing in his ‘Canon of Medicine’ and Ambroise Pare's accidental trial in 1537, which introduced a novel therapy for wounded soldiers. The modern era of clinical trials was marked by James Lind's controlled trial on scurvy in 1747, laying the foundational principles for contemporary clinical research methodologies. The progression from these early experiments to the structured, ethical, and scientifically rigorous trials of today highlights the dynamic nature of clinical research. This evolution was further shaped by the introduction of the placebo in the early 1800s and the establishment of ethical frameworks, starting with the Hippocratic Oath and later formalized by the Nuremberg Code in 1947. The development of clinical research has been instrumental in advancing medical science, with each phase of clinical trials meticulously designed to ensure the safety and efficacy of new treatments for the benefit of patient care.

Key Components of Laboratory Research

Clinical Research Facility Sciences, pivotal in the realm of medical lab science, leverage laboratory data and services extensively for disease diagnosis, monitoring, and treatment 24. These sciences are underpinned by professionals who, after obtaining a Bachelor's degree in fields such as clinical research facility science or biomedical sciences from NAACLS-accredited programs, perform crucial laboratory tests, analyze specimens, and furnish healthcare providers with critical insights into the results' significance and validity 2. Notably, these activities are conducted in laboratory settings without involving human subjects, emphasizing the distinction between clinical and laboratory research 2.

The infrastructure of laboratories is meticulously designed to support the complex and sensitive nature of laboratory tests and analyses. This includes sturdy tables and ample counter space for heavy equipment, overhead and adjustable shelving for efficient space utilization, and cabinets and drawers for organized storage. Additionally, the deployment of fume hoods, customized for specific research needs, is essential for the safe handling of chemicals. Compliance with safety regulations and proper storage of flammable items underscore the operational standards necessary for high-quality testing and analysis in medical breakthroughs 6.

The scientific process in laboratory research unfolds through several key steps: hypothesis formulation, experiment design, data collection, data analysis, and report writing. This structured approach begins with formulating a tentative explanation for a phenomenon, followed by planning and conducting experiments using appropriate methods and tools. The subsequent collection and analysis of data facilitate testing the hypothesis, culminating in the documentation of the entire process and findings in a formal report or paper 7. This systematic methodology underscores the rigorous and methodical nature of laboratory research, contributing significantly to advancements in medical lab science.

Bridging the Gap: Collaboration between Clinical and Laboratory Research

Bridging the gap between clinical and laboratory research involves fostering collaborative environments that leverage the strengths of both fields to advance medical science. Medical scientific studies bifurcate into clinical laboratory scientists, who interpret critical data for healthcare professionals, and clinical researchers, who lay the groundwork for medical education and understanding 4. This collaboration is pivotal for both building the future of medicine and administering its current benefits 4. Enhanced operational efficiency is achieved through cross-departmental synergy, reducing redundancies in resource and personnel utilization, and fostering faster adoption of best practices and innovations across the lab 8. These collaborations are exemplified by real-world success stories from renowned institutions like Mayo Clinic and Stanford Health Care, which have demonstrated the profound impact of integrated efforts on medical advancements 8.

Key strategies for effective collaboration include regular meetings to address challenges, the integration of digital communication platforms with lab databases for swift sharing of results, and the establishment of clear guidelines for consistency in sample collection and result dissemination 8. Unified objectives ensure that despite methodological differences, the end goals of improving patient care and advancing medical knowledge remain aligned 8. Furthermore, the adoption of cloud-based data systems and AI technologies not only facilitates seamless data sharing but also automates routine tasks, thereby enhancing productivity and enabling the discovery of new insights 9.

Challenges such as competition, ethics reviews, insufficient research funds, and the recruitment of project managers underscore the complexities of collaborative efforts 9. However, the benefits, including improved reputation, publication quality, knowledge transfer, and acceleration of the research process, often outweigh the costs and risks associated with collaboration 9. Collaborative relationships in Translational Medical Research (TMR) among clinicians highlight a strong willingness to collaborate, with preferences varying across different stages of research and between preferring independent and interdependent relationships 9. This willingness to collaborate is crucial for bridging the gap between clinical and laboratory research, ultimately leading to groundbreaking advancements in medical science.

Future Trends in Clinical and Laboratory Research

The future of clinical and laboratory research is poised for transformative changes, driven by technological advancements and evolving healthcare needs. Notably:

• Greater Efficiency through Automation: The integration of automation in research processes promises to streamline workflows, reducing manual labor and enhancing precision 13.

• Collaboration and Capacity Sharing: Partnerships between research institutions will facilitate shared resources and expertise, optimizing research outputs 13.

• Remote Sample Support and Diagnostic Data Interoperability: These advancements will enable more inclusive research and improved patient care by allowing data to flow seamlessly between different healthcare systems 13.

• Artificial Intelligence and Machine Learning: AI and machine learning are set to revolutionize both clinical and laboratory research by providing advanced data analysis, predictive modeling, and personalized medicine approaches 13 14.

• Staffing Solutions and Digital Workflows: Addressing staffing shortages through innovative solutions, alongside the adoption of digital workflows, will be crucial for maintaining research momentum 14.

• New Diagnostic Technologies: The development of novel diagnostic methods and technologies, including next-generation sequencing and biomarker-based screenings, will enhance disease diagnosis and treatment 14.

• Regulatory Changes and Patient-Centric Approaches: Increased FDA oversight of laboratory-developed tests and a shift towards patient-centric research models will ensure safer and more effective healthcare solutions 14 16.

• Precision Medicine and Big Data Analytics: The focus on precision medicine, supported by real-world evidence and big data analytics, will tailor treatments to individual patient needs, improving outcomes 15.

• Decentralized Clinical Trials and Digital Health Technologies: The rise of decentralized trials and digital health tools, including remote monitoring, will make research more accessible and patient-friendly 15.

• Innovation in Testing and Consumer Health: Laboratories will explore new frontiers in diagnostics, such as multi-drug-of-abuse testing and T-cell testing, while also responding to consumer health trends with at-home testing services 14 18.

These trends underscore a dynamic shift towards more efficient, patient-centered, and technologically advanced clinical and laboratory research, setting the stage for groundbreaking discoveries and innovations in healthcare 13 14 15 16 18.

Conclusion

Through this detailed exploration, we have seen the distinct yet intertwined roles that clinical and laboratory research play in the advancement of medical science and patient care. By comparing their methodologies, evolution, and collaborative potential, it becomes clear that both domains are crucial for fostering innovations that can bridge the gap between theoretical knowledge and practical healthcare solutions. The synergy between clinical and laboratory research, as highlighted by various examples and future trend predictions, establishes an essential framework for the continual improvement of medical practices and patient outcomes.

As we look toward the future, the significance of embracing technological advancements, enhancing collaboration, and adopting patient-centric approaches cannot be overstressed. These elements are pivotal in navigating the challenges and leveraging the opportunities within clinical and laboratory research landscapes. The potential impacts of such advancements on the field of medicine and on societal health as a whole are immense, underscoring the imperative for ongoing research, dialogue, and innovation in bridging the gap between the laboratory bench and the patient's bedside.

FAQs

What distinguishes clinical research from laboratory research? Clinical research involves studies that include human participants, aiming to understand health and illness and answer medical questions. Laboratory research, on the other hand, takes place in environments such as chemistry or biology labs, typically at colleges or medical schools, and does not involve human subjects. Instead, it focuses on experiments conducted on non-human samples or models.

How does a clinical laboratory differ from a research laboratory? Clinical laboratories are specialized facilities where laboratory information and services are utilized to diagnose, monitor, and treat diseases. Research laboratories, in contrast, are settings where scientific investigation is conducted to study illness and health in humans to answer medical and behavioral questions.

In what ways do clinical research and scientific research differ? Clinical research is a branch of medical research that directly applies knowledge to improve patient care, often through the study of human subjects. Scientific research, including basic science research, aims to understand the mechanisms of diseases and biological processes, which may not have immediate applications in patient care.

Can you outline the various types of medical research analysis? Medical research can be categorized into three primary types based on the study's nature: basic (experimental) research, clinical research, and epidemiological research. Clinical and epidemiological research can be further divided into interventional studies, which actively involve treating or intervening in the study subjects, and noninterventional studies, which observe outcomes without intervention.

Everything You Need to Know About Clinical Research Studies

Clinical Research Studies

In the ever-evolving landscape of medicine, clinical research studies act as the engine driving progress. These meticulous investigations pave the way for the medications we rely on, the treatments that improve lives, and the preventative measures that keep us healthy. But what exactly are clinical research studies, and how can you get involved? This comprehensive guide will equip you with all the essential knowledge.

What are Clinical Research Studies?

Clinical research studies are scientific investigations that meticulously explore the effects of new medical interventions on human participants. These interventions encompass a diverse range, including:

• Medications: Think of the medications you take daily. Before reaching pharmacies, new drugs undergo rigorous testing in clinical trials to assess their safety and efficacy.

• Surgical procedures: Novel surgical techniques are evaluated for effectiveness, safety, and potential complications through clinical research studies.

• Medical devices: From pacemakers to artificial joints, the safety and intended benefits of medical devices are demonstrably proven through clinical trials.

• Behavioral therapies: Clinical research studies assess the effectiveness of new approaches to managing chronic conditions or mental health concerns compared to traditional methods.

• Preventative measures: These studies evaluate the efficacy of new strategies for preventing diseases and promoting overall health.

1. Clinical Research Coordinator Certification: career opportunities in clinical research.

If you're interested in overseeing clinical trials and managing their daily operations, consider becoming a certified Clinical Research Coordinator ( https://app.ccrps.org/courses/Clinical-Research-Coordinator ).

2. Pharmacovigilance Certification : Suitable for the section discussing the importance of monitoring drug safety in clinical trials.

Enhance your expertise in monitoring the safety of pharmaceuticals and medical devices by pursuing a Pharmacovigilance Certification( https://app.ccrps.org/courses/pharmacovigilance-certification ).

3. CRA (Clinical Research Associate) Certification: This link can be included in parts talking about roles involving the monitoring and operational management of clinical trials.

Learn to plan and oversee clinical trials to ensure adherence to regulatory standards with a CRA Certification( https://app.ccrps.org/courses/cra ).

4. ICH-GCP (Good Clinical Practice) Training: Place this link in sections discussing the ethical and regulatory standards guiding clinical research.

Gain a thorough understanding of the international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects with ICH-GCP Training( https://app.ccrps.org/courses/ich-gcp ).

5.Clinical Trials Assistant Training: This link fits well in sections discussing entry-level positions in clinical research.

Start your career in clinical research by getting trained as a Clinical Trials Assistant( https://app.ccrps.org/courses/Clinical-Trials-Assistant-Training ), which will provide you with the necessary foundation to support clinical studies.

6. *Advanced Clinical Research Project Manager Certification*: Ideal for discussing advanced career paths in managing extensive clinical research projects.

For those aiming to lead complex clinical trials, consider the [Advanced Clinical Research Project Manager Certification( https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification ) to enhance your project management skills.

7. Advanced Principal Investigator Physician Certification: Place this link where leadership roles in clinical trials are mentioned.

If you aspire to lead clinical trials and make impactful decisions, the [Advanced Principal Investigator Physician Certification( https://app.ccrps.org/courses/Advanced-Principal-Investigator-Physician-Certification ) is an excellent pathway.

8. Medical Monitor Certification*: Include this link in parts discussing the roles focused on overseeing the medical aspects of clinical trials.

Specialize in monitoring the medical aspects of clinical trials with [Medical Monitor Certification]( https://app.ccrps.org/courses/medial-monitor-certification ), ensuring the highest standards of participant safety and study integrity.

Clinical research studies can answer specific questions about:

• New drugs, products, and therapies

• Treatments for existing conditions

• New ways of using known treatments

The Impact of Clinical Research Studies

Through clinical research studies, clinical research investigators are constantly pushing boundaries and finding new and better ways to:

• Prevent illnesses and conditions: These studies pave the way for preventative measures like vaccines and lifestyle modifications.

• Diagnose and detect diseases: New diagnostic tools and techniques are often developed through clinical research.

• Control and treat illnesses: Clinical trials play a vital role in identifying effective treatments for various conditions.

• Improve the quality of life: The discoveries made through clinical research studies have significantly improved the quality of life for those with chronic illnesses or life-threatening diseases.

Finding Clinical Research Studies: Your Gateway to Participation

Thinking about participating in a clinical research study? There are resources available to help you find the right opportunity:

• ClinicalTrials.gov : This U.S. database, sponsored by the federal government and private organizations, lists a vast number of clinical research studies. You can search for trials by location, condition, and other criteria to find studies that align with your interests.

Developed by the National Library of Medicine (NLM) in collaboration with the National Institutes of Health (NIH) institutes and the Food and Drug Administration (FDA), ClinicalTrials.gov provides easy access to information on clinical trials for various diseases and conditions.

What is Tested in Clinical Research Studies?

Clinical research studies encompass a broad spectrum of medical interventions:

• Behavioral, counseling, or psychological treatments: These are often assessed through questionnaires designed to understand patient needs and the effectiveness of the intervention.

• Drugs, medical devices, or biologics: New drugs, medical devices, and biologics like blood products, gene therapy, or vaccines undergo rigorous testing in clinical trials before becoming available to the public.

The Phases of Clinical Research Studies:

Clinical research studies are conducted in four distinct phases:

• Phase 1: This initial phase involves testing the new drug or treatment in a small group of people, typically 20 to 100 participants. The primary focus is on safety and determining the appropriate dosage.

• Phase 2: The study expands in Phase 2, with the new drug or treatment being tested on a larger group of people, usually ranging from 100 to 300 participants. Here, researchers assess the effectiveness of the intervention for the intended condition.

• Phase 3: Phase 3 trials involve an even larger group of participants, typically numbering in the hundreds or even thousands. This phase aims to confirm the effectiveness of the intervention compared to existing treatments or a placebo and gather further data on safety and side effects.

• Phase 4: After a new drug or treatment receives approval and becomes commercially available, Phase 4 studies monitor its long-term effects and safety in the general population.

Join the Movement: A Career in Clinical Research

The clinical research world is a dynamic field constantly seeking qualified professionals. If you're passionate about making a positive impact on healthcare, consider a career in clinical research. There are numerous opportunities for certified, competent, and responsible individuals to contribute to a greater and better clinical research world.

By incorporating this additional information, the blog offers a more comprehensive understanding of clinical research studies, their impact, and the various ways people can get involved.

Take courses from CCRPS and learn more on how to become a clinical research professional.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

Medical Research Jobs

The landscape of clinical research is constantly evolving, offering exciting opportunities for individuals passionate about improving human health. Here's a glimpse into some key roles in this fulfilling field (salary ranges are estimates based on 2024 data from bls.gov :

Clinical Explore Specialists:

Clinical Examine Relate (CRA): Plans and oversees clinical trials, ensuring adherence to traditions and reporting comes almost (Emolument: $50,000 - $90,000) Consider CCRPS CRA Certification.

Clinical Ask around Facilitator (CRC):** Manages the day-to-day operations of clinical trials, checking data collection, part enrollment, and tradition checking (Stipend: $43,000 - $55,000). Look for after CCRP Certification.

Clinical Trials Executive (CTM): Leads the entire clinical trial plan, overseeing budgets, timelines, and authoritative compliance (Remuneration: $70,000 - $90,000) See into CCRPS CCTM Certification.

Lab and Data Examination Experts:

Clinical Research Assistant (CRA): Performs laboratory tests following established protocols to support research studies (Salary: $35,000 - $45,000). Consider CLT Certification through CCRPS.

• Bioinformatics Analyst: Leverages computer tools and biological data to analyze complex data from clinical research labs (Salary: $75,000 - $100,000). Review CCRPS CBS Certification.

Communication and Regulatory Professionals:

• Medical Writer: Creates and edits documents for clinical trials, including protocols and reports for dissemination (Salary: $60,000 - $80,000) Target CCRPS CMW Certification.

• Regulatory Affairs Manager: Oversees the regulatory process, ensuring clinical research complies with guidelines (Salary: $95,000 - $125,000) Consider CCRPS CARM Certification.

• Regulatory Affairs Specialist: Develops procedures for clinical trial applications, reviews protocols, and maintains regulatory documentation (Salary: $55,000 - $100,000) Explore Pharmacovigilance Certification through CCRPS.

Clinical research and career opportunities :

1. CRA Certification (Clinical Research Associate):

Clinical Research Associate (CRA): Plans and oversees clinical trials, ensuring adherence to regulations and accurate reporting (Salary: $50,000 - $90,000). Consider obtaining [CCRPS CRA Certification](https://app.ccrps.org/courses/cra) to advance your expertise in clinical trial management.

2. CRC Certification (Clinical Research Coordinator):

Clinical Research Coordinator (CRC): Manages day-to-day operations of clinical trials, including data collection and participant enrollment (Salary: $43,000 - $55,000). Enhance your capabilities with CCRP Certification ( https://app.ccrps.org/courses/Clinical-Research-Coordinator ) tailored for coordinators.

3. *CCTM Certification* (Clinical Trials Manager):

Clinical Trials Manager (CTM): Leads the entire clinical trial program, overseeing budgets, timelines, and regulatory compliance (Salary: $70,000 - $90,000). Explore [CCRPS CCTM Certification](https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification) for comprehensive management skills.

4. CLT Certification (Clinical Laboratory Technician):

Clinical Research Assistant: Performs laboratory tests to support research studies (Salary: $35,000 - $45,000). Consider enhancing your laboratory skills with [CLT Certification through CCRPS](https://app.ccrps.org/courses/Clinical-Lab-Technician-Certification).

5. CBS Certification* (Bioinformatics Specialist):

Bioinformatics Analyst: Leverages computer tools to analyze biological data from clinical research labs (Salary: $75,000 - $100,000). Improve your data analysis capabilities with [CCRPS CBS Certification](https://app.ccrps.org/courses/Computational-Bioinformatics-Specialist-Certification).

6. CMW Certification* (Certified Medical Writer):

Medical Writer: Creates and edits clinical trial documents (Salary: $60,000 - $80,000). Target your writing skills with CCRPS CMW Certification (https://app.ccrps.org/courses/Certified-Medical-Writer-Certification).

7. *CARM Certification (Certified Affairs Regulatory Manager):

Regulatory Affairs Manager: Ensures clinical research compliance with guidelines (Salary: $95,000 - $125,000). Consider advancing your career with [CCRPS CARM Certification](https://app.ccrps.org/courses/Certified-Affairs-Regulatory-Manager-Certification).

8. Pharmacovigilance Certification:

Regulatory Affairs Specialist: Develops procedures for clinical trial applications and maintains regulatory documentation (Salary: $55,000 - $100,000). Explore the specialized field with [Pharmacovigilance Certification through CCRPS](https://app.ccrps.org/courses/pharmacovigilance-certification).

Skills and Background:

Medical ask almost livelihoods as often as possible require a establishment in science or pharmaceutical, with specialization in ranges like immunology or pharmacology. Strong informative aptitudes, fundamental considering, and picky thought to detail are critical. Practical communication and collaboration with colleagues and healthcare specialists are additionally crucial.

A Day in the Life:

A restorative researcher's day might incorporate analyzing data from tests, examining critical composing, going to conferences, and communicating revelations through reports and presentations.

Make a Difference:

Medical examine is at the cutting edge of helpful headways. By contributing to this field, you'll play a basic portion in making unused drugs, moving forward diagnostics, and inevitably, progressing human prosperity and well-being.

Remember: This is not an careful list. Various other energizing openings exist in therapeutic examine. Examine help to find your idealize fit!

(CRC)

Clinical Research Coordinator Certification

Guide To Becoming A Clinical Research Coordinator 

What is a Clinical Research Coordinator

Clinical research coordinators play a crucial role in administering clinical trials, overseeing various aspects such as data collection, participant engagement, and adherence to trial standards. As of 2024, their responsibilities have expanded to include ensuring smooth trial operations and effective communication with subjects. Here's a revised version of your content:

Clinical research coordinators are pivotal in the administration of clinical trials. Their primary responsibilities typically involve administering questionnaires, informing participants about study objectives, collecting data, and managing all trial procedures. In 2024, their roles have evolved to encompass strict adherence to established trial standards and active involvement in participant recruitment.

Effective engagement with subjects is paramount for clinical research coordinators, necessitating strong communicative and interpersonal skills.

Responsibilities

Clinical research coordinators shoulder a multitude of responsibilities, all critical to the success of their endeavors:

1. Maintaining meticulous records of all studies in compliance with guidelines.

2. Adhering rigorously to ethical standards governing research.

3. Ensuring compliance with regulatory standards.

4. Administering questionnaires and other study protocols.

5. Managing the research budget efficiently.

6. Overseeing the smooth execution of trials.

7. Engaging with participants to address concerns and gather insights.

8. Ensuring functionality and availability of necessary equipment and supplies.

9. Participating actively in participant recruitment efforts.

10. Collaborating with laboratories to share findings.

Requirements

Qualifications for clinical research coordinators vary depending on location and employer. However, common requirements as of 2024 include:

• An associate nursing degree or related field.

• A minimum of two years' experience in the healthcare industry.

• An analytical mindset and keen attention to detail.

• Exceptional interpersonal skills for effective participant engagement.

• Willingness to pursue continuous learning opportunities independently.

• Strong organizational abilities.

• Excellent verbal and written communication skills.

In a dynamic field like clinical research, staying abreast of advancements and regulations is essential for success.

This revision integrates the existing content with updates reflecting the current landscape in 2024, emphasizing the evolving nature of clinical research coordination.

Roles And Duties Of Clinical Trial Coordinator

In 2024, the part of a clinical investigate facilitator includes overseeing clinical inquire about at investigate destinations in understanding with convention, ICH-GCP rules, and other administrative necessities. Understanding the errands of a clinical investigate facilitator requires understanding into the timeline of a inquire about location, which regularly unfurls in three stages:

Some time recently Beginning the Clinical Trial:

During this arrange, consider organizers assemble and total surveys from supports and different Contract Inquire about Organizations (CROs). Clinical inquire about facilitators at that point collect information from the foremost examiner and transfer it back to partners. Supports select areas based on achievability survey reactions and conduct pre-site evaluation visits to finalize taking an interest sites.

Sites conducting investigate must hold clinical trial facilitator certification to continue with agent gatherings, regularly held at universal or national levels. Some time recently commencing the trial, clinical inquire about facilitators are possessed with submitting different reports to the morals committee, counting subject journals, investigators' CVs, clinical investigate assentions, convention signature pages, certification, indemnification letters, protections certificates, clear Case Report Shapes (CRFs), and ponder logs.

Conduct Amid the Clinical Trial:

Clinical investigate facilitators must have a exhaustive understanding of the think about convention, counting avoidance and consideration criteria. They get educated assent from subjects, as spoken to by Central Examiners, and collect pre-medical records. Facilitators oversee planned visits agreeing to the examination convention, guaranteeing compliance with prohibition and consideration criteria some time recently selecting qualified subjects. Taking after each visit, facilitators compile information into case reports, keeping up overhauled records all through the trial.

Coordinators are capable for overseeing ponder medicate responsibility, utilizing Intelligently Web Reaction Frameworks (IWRS) and Intuitively Voice Reaction Frameworks (IVRS) to record subject visits. Legitimate capacity and dealing with of investigational items, counting temperature observing, are pivotal. Facilitators too collect essential information on unfavorable occasions, observing lab reports and securing Vital Agent signatures.

After Completing the Clinical Trial:

Upon trial completion, facilitators audit and upgrade all reports some time recently closure, guaranteeing precision and completeness. Clinical Inquire about Partners (CRAs) confirm materials on the trial's last day. Facilitators help in chronicling records at the location, keeping up records for 15-20 years.

In outline, clinical investigate facilitators play a essential part in managing clinical trials at the location level, serving as a crucial connect between morals committees, examiner destinations, and supports. Their fastidious administration guarantees compliance, information judgment, and the fruitful execution of clinical investigate endeavors.

Education Requirements Of A Clinical Research Coordinator

To set out on the travel of getting to be a Clinical Investigate Facilitator in 2024, one must take after a organized way. Here are the steps you require to take:

Step 1: Tall School Graduation

Completion of tall school lays the establishment for your scholastic travel. Center on subjects like material science, chemistry, science, arithmetic, measurements, and communication to construct a solid base for your future studies.

Step 2: Bachelor's Degree

Seek out colleges and colleges advertising bachelor's degrees in wellbeing sciences. These programs prepare understudies with the vital devices and techniques for research facility work, definition of solutions, and conducting clinical trials and thinks about. Whether through on-campus or online courses, guarantee the educational programs covers both authoritative and logical angles basic for a clinical investigate coordinator.

Step 3: Work Experience

Gain down to earth encounter by volunteering at clinical trials and securing entry-level positions in teach or investigate research facilities. Investing a year or two in this capacity will give profitable hands-on encounter pivotal for certification and employment.

Step 4: Online Graduate Certificate

Consider seeking after an online graduate certificate in clinical investigate organization. These programs regularly span 18 credit hours, displaying devotion and improving your career prospects. Courses center on administrative and communication aptitudes, inquire about plan, location administration, information administration, measurements, member security contemplations, and more. These credits can regularly be exchanged to a master's program in the same institution.

Step 5: Master's Degree (Online or On-site)

Advance your information and career prospects by getting a master's degree, either online or through conventional on-site courses. Master's programs dive more profound into essential administrative issues and clinical inquire about checking, giving comprehensive planning for certification.

Step 6: Get Certification

To hone as a certified Clinical Inquire about Facilitator, you must pass an exam and get certification. Organizations like CCRPS offer globally recognized certification programs. Upon certification, you'll be well-equipped to set out on a satisfying career in clinical inquire about coordination.

By perseveringly taking after these steps, trying people can clear the way towards getting to be capable Clinical Inquire about Facilitators in the energetic field of restorative inquire about.

Salary Of A Clinical Research Coordinator

Salary of a Clinical Research Coordinator

How Much is a Clinical Research Coordinator’s Salary?

As of Walk 5, 2024, the normal yearly pay for a Inquire about Facilitator in the Joined together States is $80,570. This deciphers to around $38.74 an hour, $1,549 per week, or $6,714 per month.

While pay rates for Investigate Facilitators can shift essentially, with a few gaining as much as $112,500 yearly and others as moo as $21,500, the larger part drop inside the extend of $61,000 (25th percentile) to $99,500 (75th percentile). Beat workers, speaking to the 90th percentile, can make up to $110,000 per year.

The impressive variety in compensations, up to $38,500, recommends various openings for progression and expanded pay based on components such as expertise level, area, and a long time of experience.

Based on later work posting action, the Investigate Facilitator work advertise in the Joined together States is not especially dynamic. Be that as it may, certain cities offer higher-than-average pay rates for Inquire about Facilitators. Among the beat 10 most noteworthy paying cities are Berkeley, CA; Modern York City, NY; and Renton, WA. These cities offer normal pay rates surpassing the national normal, with Berkeley, CA, driving with an normal compensation surpassing $97,543.

While migrating to these cities may show openings for financial progression, it's basic to consider components such as the fetched of living and the generally little variety in normal compensations among the best cities. This recommends restricted potential for critical wage increments based exclusively on area.

Free Online Clinical Research Coordinator Training

Free courses for CRC training are available is specific subjects

You can search for free courses on the following subjects to get training that a CRC may benefit from:

• Medical Ethics Course: - In this course, the professors introduce important values, which include autonomy, non-maleficence, dignity, justice, and honesty. The students consider how to develop a framework for creating ethical decisions that were informed by laws and values. You will discuss ethical issues, like favorable cost-benefit ratio, participant selection, and confidentiality. It is one of the best clinical research coordinator certifications online courses to help you to crack the exams.

• Clinical Research Principles Course: - This clinical research coordinator certifications online course will provide an overview of the process of clinical research, development, and the history of it. Here the students can quickly learn the management skill, which includes the practice guidelines of clinics. You will also learn about the roles of research team members and development phases of the clinical trials. 

• Medical Terminology Course: - This clinical research coordinator certification online courses cover up the standard medical terminology which uses up in the clinical research field. This knowledge will help enhance your effectiveness at managing the data and quality control. 

• Health Information And The Law Course: - In this clinical research coordinator certifications online course, the students need to understand the overview of guidelines and the regulations which protect the human subjects and ensures research integrity. T You will learn about the obligations of the regulatory bodies. Here, students will even discuss the types of violations constituted by scientific misconduct and consider their consequences. 

• Introduction To The Health Records Courses: - This clinical research coordinator certifications online explore the confidentially and its purpose. This course will consist of how to use medical records for planning, the caring of the patient, and how to use laws for these records.

• Study Of Financing Course: - This clinical research coordinator certifications online will provide you an overview of funding management of the study. Here students get to learn how to submit the proposals and how to create them. This course compiles the financial regulations, which consider the indirect and the direct cost.

• Medical Device History: - In this clinical research coordinator certifications online course, it will provide you to explore the current trends which are affecting the research, which also explores the history of devices in medical. Students will be provided with a lot of case studies that can be considered from a business, medical, ethical, and also legal perspective.

These are a few free clinical research coordinator certifications online courses that you can go for preparing for your clinical research certifications. These courses can help you a lot in every perspective of exams, but the best option is to take a course that can provide you with in-depth accredited training. Overall, getting accredited certification from a trusted body such as CCRPS is the best option in showing employers your competency for coordinator roles.

CRC Course Syllabus

Introduction to CRC

1. Accreditation Council For Clinical Research & Education for CCRPS

   FREE PREVIEW

2. Duties and Responsibilities of Clinical Research Coordinators

3. Employment Advancement for Clinical Research Coordinators

4. Process Map of A Sponsored Clinical Trial Study

5. Orientation Manual for Clinical Research Coordinator

1. Protocols and Guidelines

   1. SOPs and MOPs

   2. SOP Template

   3. MOP Outline

   4. MOP Example

2. Clinical Research Coordinator Toolkit

   1. Routine Site Visit Report

   2. Adverse Event Tracking Log

   3. Chart Audit Tool

   4. Regulatory File Review Tool

   5. Monitoring Log

3. ICH GCP

   1. An Introduction to Clinical Research

   2. An Overview of ICH GCP

   3. Code of Federal Regulations

   4. CFR 21 Part 11

   5. Sponsor/CRO Responsibilities

   6. ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

   7. ICH GCP Section 4.8 Informed Consent

      FREE PREVIEW

   8. Reporting Responsibilities of the Investigators

   9. Ethics of Research Involving Children

   10. Ethics of Research Involving Mentally Incapacitated

       FREE PREVIEW

   11. Ethics of Research Involving Pregnant Women and Fetuses

   12. Ethics of Research Involving Prisoners

   13. ICH GCP E6 and E2A - Adverse Events

   14. Safety of Human Subjects in Clinical Research

       FREE PREVIEW

   15. ICH GCP 5.5 Trial Management – Data Handling and Record Retention

   16. a) Common Terminology Used In Clinical Research

   17. b) Commonly Used Abbreviations and Terms in Clinical Research

   18. ICH GCP Quiz

4. Advanced Clinical Trials Foundations

   1. Designs of Clinical Trials

   2. Phases of Clinical Trials

      FREE PREVIEW

   3. Stakeholders in Clinical Research and Their Relationships

   4. Contract Research Organization- CRO

      FREE PREVIEW

   5. Randomized Controlled Trials

      FREE PREVIEW

   6. Types of Monitoring Visits

      FREE PREVIEW

   7. Site and Investigator Selection

   8. Site Initiation Visit (SIV)

   9. Site Qualification Visit

   10. Routine Monitoring Visit

   11. Site Close Out Visit

   12. Source Documents and Informed Consent Forms

   13. Quality Monitoring Quiz Modules 1-15

   14. Inclusion Exclusion Criteria in Clinical Research

   15. Interactive Voice Response System - IVRS

   16. The Trial Protocol

       FREE PREVIEW

   17. Protocol Deviations and Violations

   18. Institutional Review Board

   19. Quality Control in Clinical Research

   20. Blinding in Clinical Trials

   21. Communication between Blinded and Unblinded Staff

   22. Investigational Product Storage and Dispensing

       FREE PREVIEW

   23. Investigational Product Accountability in Clinical Trials

   24. Quality Monitoring Quiz

   25. Adverse Drug Reactions

   26. Basics of Adverse Event Monitoring

   27. Adverse Event Reporting

   28. Safety Reporting Requirements for Sponsor Investigators of An IND

   29. IND and NDA Process

   30. Guidelines for Designing and Completing Case Report Forms

       FREE PREVIEW

   31. Do’s and Don’ts of a Case Report Form Design

   32. Clinical Trial Management System-CTMS

       FREE PREVIEW

5. Compliance and Regulations

   1. Regulatory Documents in Clinical Research

   2. Regulatory Affairs

   3. Essential Regulatory Documents Guidance and Binder Tabs (Part 1)

      FREE PREVIEW

   4. Essential Regulatory Documents Guidance and Binder Tabs (Part 2)

      FREE PREVIEW

   5. Electronic Regulatory Submission and Review

      FREE PREVIEW

   6. Financial Disclosure- Duties and Strategies for Clinical Studies

   7. Financial Disclosures and Conflicts of Interest in Clinical Research

   8. FDA Form 1572 - Part 1

      FREE PREVIEW

   9. FDA Form 1572 - Part 2

   10. Delegation of Authority Log – DOAL

   11. Investigators Brochures

   12. Protocol Continuing

   13. IND Application

   14. Trial Master File and DIA Model

       FREE PREVIEW

   15. Trial Master File Reference Guide

   16. Regulatory Training Quiz (20 Questions)

6. Audit and Inspections

   1. Audits and Inspections in Clinical Trials

      FREE PREVIEW

   2. FDA Warning Letter

   3. Site FDA Audit Inspection Checklist

   4. How to Survive Through an FDA Inspection

   5. Do and Don’ts during an FDA Inspection

   6. Audits and Inspection Quiz

7. Subject Recruitment and Retention

   1. Compliance Requirements in Clinical Trials

   2. Subject Recruitment and Retention (Part 1)

      FREE PREVIEW

   3. Subject Recruitment and Retention (Part 2)

   4. Increasing Subject Compliance in Clinical Trials

   5. Ethical Consideration Associated with Investigator Payment and Patient Recruitment

   6. Advertisement Aid in Subject Recruitment and Retention

8. Misconduct and Fraud

   1. Scientific Misconduct in Research and How to Prevent It

      FREE PREVIEW

   2. Misconduct in Research – Detecting Falsification

9. Statistics and Data Management of Clinical Trials

   1. Data Management In Clinical Research

   2. Good Clinical Data Management Protocol

10. Financial Management of Clinical Trials

    1. Financial Management Fundamentals

    2. Developing A Trial Budget

    3. Budget Worksheet

11. Final Examination

    1. Competency Exam (52 Questions)

Are you looking for a comprehensive and reliable training program for clinical research coordinator certification?

CCRPS Clinical Research Coordinator Training provides the most advanced, yet easy-to-follow coverage of GCP guidelines. Our program exceeds expectations with checklists, images, and examples that help students apply concepts learned. Upon completion of our program, students are able to pass certification exams with flying colors and are trusted by employers all over the world. Make the smart choice and choose CCRPS for CRC training.

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What Is ICH GCP Certification 2024

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What Is ICH GCP Certification?

ICH, which stands for the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, is a pivotal global organization shaping the landscape of clinical trials in 2024. Responsible for setting stringent standards, ICH ensures that clinical trials involving human subjects adhere to rigorous regulatory frameworks.

In essence, ICH oversees the implementation of Good Clinical Practice (GCP) guidelines, ensuring that the planning, execution, and documentation of clinical trials are conducted ethically and with scientific integrity at every phase of the research process.

For those seeking to enhance their understanding of ICH GCP guidelines, there's an opportunity to access free online training, providing invaluable insights into the intricacies of conducting ethical and scientifically sound clinical trials in 2024.

You can demo ich gcp training free online here.

What is the purpose of GCP Certification? 

In 2024, GCP Certification, short for Good Clinical Practice Certification, serves as a crucial acknowledgment of an individual's proficiency and expertise in implementing regulatory guidelines across all facets of their work.

Why is it significant?

In the realm of clinical research, possessing GCP certification is indispensable for success. It's not just a matter of preference; it's a necessity. Any organization involved in clinical research endeavors must ensure that their personnel comprehensively grasp the ICH guidelines and are certified to conduct scientific studies accordingly. In fact, many companies provide certification programs for their employees even before they commence their duties. This underscores the paramount importance of GCP certification in the clinical research industry landscape of 2024.ICH GCP Attestation Form

If you're looking to explore a career in the innovative and quickly growing field of clinical research, you'll need to ensure you get the proper Good Clinical Practice certification.

GCP Certification

Are you seeking a GCP refresher online course or comprehensive initial advanced GCP training in 2024? Look no further. Our cutting-edge GCP certification courses are designed to equip you with all the necessary tools to obtain your certification efficiently.

In today's fast-paced world, attending in-person classes for GCP certification training may not always be feasible. That's why our innovative and user-friendly online courses offer a convenient alternative. We understand the importance of receiving top-notch training from experts well-versed in the ICH GCP guidelines to propel your career forward.

At CCRPS, excellence is our standard. Each ICH GCP module we offer is crafted with meticulous attention to detail, ensuring that you receive the highest level of instruction possible. It's time to invest in yourself and receive the refresher training you deserve from professionals who understand how to facilitate your advancement.

Whether you're an ethics committee member, clinical research staff member, or a student embarking on a career in clinical research, our training programs are tailored to meet your needs and set you up for success in the dynamic field of clinical research in 2024.

Good Clinical Practice Training Certificate

How can CCRPS propel your career in 2024?

At CCRPS, we're dedicated to equipping individuals in or aspiring to join the clinical trial industry with the necessary knowledge and training conveniently accessible at their fingertips. We understand that committing hours to classroom study isn't always feasible amidst your professional responsibilities. That's why we've developed our comprehensive GCP refresher course, designed to be completed entirely online.

Enrolling in our course offers you the opportunity to delve into advanced-level content to prepare for your Good Clinical Practice Certification testing.

What benefits await you upon enrollment in our practice training?

While GCP certification is mandatory for all clinical research professionals, its significance is particularly pronounced for certain groups:

• Investigators representing drug companies, research centers, hospitals, and more.

• Members of ethics committees.

• Clinical research staff, including clinical research associates, coordinators, trial managers, etc.

• Students aspiring to enter the clinical research industry.

Who should consider enrolling in CCRPS's groundbreaking training courses?

Whether you're already a seasoned clinical research professional or aspiring to become one, global recommendations underscore the importance of receiving GCP training and certification. Beyond being a minimum requirement, GCP certification holds several key advantages:

• It serves as a formal international validation of an individual's eligibility to work in the clinical research field.

• Organizations and companies rely on GCP-certified professionals to ensure compliance with industry regulations and guidelines.

• GCP training imparts essential knowledge of clinical research regulations to participants.

• Pharmaceutical, biotech companies, and contract research organizations prioritize hiring GCP-certified employees.

In the ever-evolving landscape of the clinical research industry in 2024, ICH GCP training has never been more crucial. Stay ahead of the curve and ensure your knowledge remains current with CCRPS's online practice training courses.

Experience the transformative impact on your clinical research career with our innovative approach to preparation and practice. Elevate your skills and stay abreast of industry developments with CCRPS today!

Download our ICH GCP Attestation Form

Good Clinical Practice GCP Training

Click this link to demo our ICH GCP training free online here!

Good Clinical Practice Training Certificate Syllabus

Introduction to Clinical Research, ICH GCP, and CFR

• An Introduction to Clinical Research

• An Overview of ICH GCP

• Code of Federal Regulations

• CFR 21 Part 11

Roles and Responsibilities (Sponsor/CRO, IRB, and Investigator)

• Sponsor/CRO Responsibilities

• 13 Principles, IRB, & Investigator Roles

Informed Consent & Patient Safety

• Informed Consent

• Safety of Human Subjects in Clinical Research

Adverse Event Reporting & Responsibilities

• Reporting Responsibilities of the Investigators

• Adverse Events

Ethical Research in Vulnerable Populations

• Ethics of Research Involving Children

• Ethics of Research Involving Mentally Incapacitated

• Ethics of Research Involving Pregnant Women and Fetuses

• Ethics of Research Involving Prisoners

Trial Management, Data Handling, and Record Retention

• Trial Management – Data Handling and Record Retention

• Common Terminology Used In Clinical Research

• Commonly Used Abbreviations and Terms in Clinical Research

ICH GCP Certification

• ICH GCP Certification Exam

ICH GCP Resources

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) 

FDA resource for E6 r2 addendum (also included in course)

Good Clinical Practice Resource Guide

Division of Microbiology and Infectious Diseases December 2015

WHO ICH GCP Handbook

WHO Library Cataloguing-in-Publication Data Handbook for good clinical research practice (GCP):

Guidance for implementation

ICH GCP Jobs

Linkedin Resource of ICH GCP related jobs and roles

GCP Network

Latest trials, website updates, and more

Take courses from CCRPS and learn more on how to become a clinical research professional.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

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ICH GCP Guidelines

The ICH GCP guidelines provide public assurance that trial subjects' rights, security and well-being are protected in accord with the principles which have their source from Helsinki Declaration. Compliance ensures credible clinical data; 15 points present a unified standard for European Union (EU), Japan & United States to facilitate mutual acceptance by regulatory authorities across those jurisdictions currently compliant with WHO's good practices along side Australia Canada Nordic countries+World Health Organization

This principle has been developed with all their current good clinical practices of the European Union, Japan and USA in addition to those from Australia Canada Nordic countries World Health Organization (WHO). The guidelines established within this document may also be applied during other types medical trials which could have an effect on individual subjects' safety or well being.

ICH GCP Training Free

Here are some ICH GCP training free online guidelines. Make a quizlet or copy the ich gcp guidelines quizlet, then manually rewrite each of these into an individual card that you can easily remember because it's all on one page! To review them more effectively – combine any two cards together if they both pertain to something related in theme (examples: "Committee" & “Implementation”). Continue condensing words and combining sections until down from 50-100 flashcards; after doing so take time out every day this week before your exam(s) for practice reviewing what has been learned thus far by going through each set again slowly but thoroughly while listening carefully

Now you can get internationally accredited ICH GCP certification for $50 through CCRPS course which includes several examples in each video to solidify your knowledge.

ICH GCP Guidelines

The ICH GCP guidelines, including ich gcp e6, provides public assurance that the rights, security and also well-being of trial subjects are protected in accord with the principles which have their source in the Declaration of Helsinki. In addition, compliance ensures credible clinical trial data. The 15 ICH GCP principles presents a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. The principle has been developed with all their current good clinical practices of the European Union, Japan, and the USA, in Addition to those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). This principle ought to be followed when generating. The principles established in this guideline may also be applied to other clinical investigations which might have an influence on the security and well-being of individual subjects.

ICH GCP Training Free

In order to self-learn ich gcp training free online:

1) make a quizlet account (or use the ich gcp guidelines quizlet)

2) manually rewrite each of the guidelines below into quizlet (this is ESSENTIAL in getting the guidelines to stick in your brain!)

3) continue condensing the words and combining guidelines until you’re down to 50-100 flashcards

4) review set 2-3 times and delete cards to clearly remember

5) continue to review and delete cards until you have it memorized!

While our ICH GCP training course Is only $50 it is essential to learning to applying ich gcp guidelines in an advanced method, you should be able to remotely memorize the guidelines on your own for free as an expert adult learner.

ICH GCP GLOSSARY

While our ICH GCP training course is essential to learning to applying ich gcp guidelines in an advanced method, you should be able to remotely memorize the guidelines on your own for free as an expert adult learner.

1. ICH GCP GLOSSARY

1.1 Adverse Drug Reaction (ADR)

From the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) could not have been established: all noxious and unintended responses to a medicinal product related to any dose ought to be considered adverse drug reactions. The term responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable chance, i.e. the connection can't be ruled out. Regarding marketed medicinal products: a reaction to a drug that is noxious and unintended and that occurs at doses normally utilized in man for prophylaxis, diagnosis, or treatment of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.4 Applicable Regulatory Requirement(s)

Any regulation (s) and law (s) addressing the conduct of clinical trials of investigational products.

1.5 Approval (in relation to Institutional Review Boards)

The affirmative decision of the IRB that the clinical trial was reviewed and could be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the relevant regulatory requirements.

1.7 Audit Certificate
A statement of confirmation by the auditor that an audit has happened. 1.9 Audit Trail
Documentation which allows reconstruction of the class of occasions. 1.10 Blinding/Masking

A process where a couple of parties into this trial are kept unaware of the treatment assignment(s). Single-blinding usually indicates the topic (s) being unaware, and also double-blinding usually indicates the topic (s), investigator(s), track, and, sometimes, data analyst(s) being unaware of the treatment assignment(s).

1.11 Case Report Form (CRF)

A printed, optical, or electronic document designed to record all the protocol required data to be recorded to the sponsor on each trial field.

1.12 Clinical Trial/Study

Any investigation in human subjects meant to discover or verify the clinical, psychiatric or other pharmacodynamic effects of nvestigational product(s), or to identify any adverse reactions to an investigational product(s), or to research absorption, distribution, metabolism, and excretion of an investigational product(s) together with the goal of ascertaining its security and/or effectiveness.

1.13 Clinical Trial/Study Report

A written outline of some trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, where the clinical and statistical description, presentations, and analyses are fully integrated into one report (see the ICH Guideline for Structure and Content of Clinical Study Reports).

1.14 Comparator (Product)

An investigational or marketed product (i.e., active control), or placebo, used as a benchmark in a clinical investigation.

1.15 Compliance (in relation to trials)

Adherence to all of the trial-related needs, Good Clinical Practice (GCP) requirements, and the relevant regulatory requirements.

1.17 Deal

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and duties , if appropriate, on financial issues. The protocol could serve as the foundation of a contract.

1.18 Coordinating Committee

A committee that a sponsor may organize to coordinate with the behavior of a multicentre trial.

1.19 Coordinating Investigator

An employee assigned the responsibility of the coordination of investigators at several centers participating in a multicentre trial.

1.20 Contract Research Organization (CRO)

A individual or a business (commercial, academic, or other) contracted by the sponsor to do at least one of a host's trial-related responsibilities and purposes.

1.21 Immediate Access

Permission to examine, analyze, verify, and reproduce any records and reports which are important to analysis of a medical trial. Any celebration (e.g., national and international regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable measures within the constraints of the applicable regulatory requirement(s) to keep the confidentiality of subjects' identities and sponsor's proprietary information.

1.22 Documentation

All documents, in any kind (such as, but not restricted to, written, digital, magnetic, and optical records, and tests, x-rays, and electrocardiograms) that describe or record the methods, behavior, or effects of a trial, and the factors affecting a trial, and the action taken.

1.23 Critical Documents

Documents that individually and collectively permit evaluation of the behavior of a study and the quality of the data generated.

1.24 Good Clinical Practice (GCP)

A benchmark for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that offers assurance that the data and reported results are credible and accurate, and the rights, ethics, and confidentiality of trial subjects are protected.

1.25 Independent Data-Monitoring Committee (IDMC/Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

A separate data-monitoring committee which could be determined by the sponsor to assess at intervals the progress of a clinical trial, the safety information, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, change, or discontinue a trial.

1.26 Impartial Witness

A person, who's independent of this trial, that can't be unfairly influenced by people associated in this trial, who attends the informed consent process if the subject or the subject's legally acceptable representative can't read, and who reads the informed consent form and any other written information provided to the topic.

1.27 Independent Ethics Committee (IEC)

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of caregivers and non-medical associates, whose duty is to make sure the security of their rights, security and well-being of human issues involved in an investigation and to provide public assurance of the protection, by, among other things, reviewing and approving / providing appropriate view on, the trial procedure, the arrangement of the investigator(s), facilities, and the processes and material to be utilized in obtaining and documenting informed consent of the trial subjects.

1.28 Informed Consent

A procedure in which a subject voluntarily confirms his or her willingness to take part in a specific trial, after being informed of all details of the trial that relate to the subject of choice to engage. Informed consent is documented by way of a written, signed and dated informed consent form.

1.29 Inspection

The action by a regulatory authority(ies) of conducting an official review of documents, records, facilities, and some other sources which are deemed by the authority(ies) to be associated with the clinical trial which could be found in the website of this trial, in the host's or contract study organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

1.30 Institution (medical)

Any private or public entity or agency or medical or dental facility where clinical trials have been conducted.

1.31 Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-scientific associates, whose duty is to guarantee the security of their rights, security and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and substance to be utilized in obtaining and documenting informed consent of the trial subjects.

1.33 Investigational Merchandise

A pharmaceutical form of an active ingredient or placebo being tested or used as a benchmark in a clinical trial, such as a product with a marketing authorization when used or assembled (formulated or packaged) in a sense different from the approved form, or if used for an unapproved indication, or when used to get additional information regarding an approved use.

1.34 Partner

A individual accountable for the behavior of this clinical trial at a trial website. When a trial has been conducted by a group of people at a trial site, the investigator is the responsible leader of the group and might be known as the researcher. See also Subinvestigator.

1.35 Investigator / Institution

An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements".

1.36 Investigator's Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigator’s Brochure).

1.37 Legally Acceptable Representative

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.

1.38 Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.39 Monitoring Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.

1.40 Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

1.41 Nonclinical Study
Biomedical studies not performed on human subjects.
1.42 Opinion (in relation to Independent Ethics Committee)
The judgement and/or the advice provided by an Independent Ethics Committee (IEC). 1.43 Original Medical Record
See Source Documents (Below in 1.52).
1.44 Protocol

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

1.45 Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol. 1.46 Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

1.47 Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

1.48 Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

1.49 Regulatory Authorities

Bodies with the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity, or - is a congenital anomaly/birth defect (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.51 Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

1.52 Source Documents

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

1.53 Sponsor

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

1.54 Sponsor-Investigator

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

1.55 Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

1.56 Subinvestigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.

1.57 Subject/Trial Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

1.58 Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

1.59 Trial Site
The location(s) where trial-related activities are actually conducted. 1.60 Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.61 Vulnerable Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

1.62 Well-being (of the trial subjects)
The physical and mental integrity of the subjects participating in a clinical trial.

2. THE PRINCIPLES OF ICH GCP

2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

2.4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation.

2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

2.12 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.

3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)

3.1 Responsibilities

3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.

3.1.2 The IRB/IEC should obtain the following documents: trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be provided to subjects, Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator’s current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfil its responsibilities. The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following: - approval/favourable opinion; - modifications required prior to its approval/favourable opinion; - disapproval / negative opinion; and - termination/suspension of any prior approval/favourable opinion.

3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.

3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year. 3.1.5 The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when, in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects.

3.1.6 When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable representative (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials.

3.1.7 Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable representative is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e. in emergency situations).

3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.

3.1.9 The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.

3.2 Composition, Functions and Operations

3.2.1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: (a) At least five members. (b) At least one member whose primary area of interest is in a nonscientific area. (c) At least one member who is independent of the institution/trial site. Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter. A list of IRB/IEC members and their qualifications should be maintained.

3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).

3.2.3 An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present.

3.2.4 Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion and/or advise.

3.2.5 The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC.

3.2.6 An IRB/IEC may invite nonmembers with expertise in special areas for assistance.

3.3 Procedures

The IRB/IEC should establish, document in writing, and follow its procedures, which should include:

3.3.1 Determining its composition (names and qualifications of the members) and the authority under which it is established.

3.3.2 Scheduling, notifying its members of, and conducting its meetings. 3.3.3 Conducting initial and continuing review of trials.
3.3.4 Determining the frequency of continuing review, as appropriate.

3.3.5 Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.

3.3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial.

3.3.7 Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see 4.5.2).

3.3.8 Specifying that the investigator should promptly report to the IRB/IEC: (a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4). (b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2). (c) All adverse drug reactions (ADRs) that are both serious and unexpected. (d) New information that may affect adversely the safety of the subjects or the conduct of the trial.

3.3.9 Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning: (a) Its trial-related decisions/opinions. (b) The reasons for its decisions/opinions. (c) Procedures for appeal

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of its decisions/opinions.

of its decisions/opinions.

3.4 Records

The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

4. INVESTIGATOR

4.1 Investigator's Qualifications and Agreements

4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).

4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.

4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.

4.1.4 The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

4.2 Adequate Resources

4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.

4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.

4.2.3 The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.

4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

4.3 Medical Care of Trial Subjects

4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.

4.3.2 During and following a subject's participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.

4.3.3 It is recommended that the investigator inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.

4.3.4 Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.

4.4 Communication with IRB/IEC

4.4.1 Before initiating a trial, the investigator/institution should have written and dated approval/favourable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.

4.4.2 As part of the investigator's/institution’s written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, the investigator/institution should supply a copy of the updated Investigator’s Brochure to the IRB/IEC.

4.4.3 During the trial the investigator/institution should provide to the IRB/IEC all documents subject to review.

4.5 Compliance with Protocol

4.5.1 The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given approval/favourable opinion by the IRB/IEC.

The investigator/institution and the sponsor must sign the protocol, or another contract, to confirm arrangement.

4.5.2 The investigator shouldn't implement any deviation from, or modifications of this protocol without agreement by the sponsor and prior review and documented approval/favourable opinion in the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., alter in track (s), change of phone number(s)).

4.5.4 The investigator may implement a deviation from, or a reversal of, the protocol to eliminate an immediate hazard(s) to trial subjects without previous IRB/IEC approval/favourable opinion. When possible, the implemented deviation or change, the causes of this, also, if appropriate, the proposed protocol amendment(s) ought to be filed: (a) into the IRB/IEC for inspection and approval/favourable view, (b) to the sponsor for agreement and, when necessary, (c) into the regulatory authority(ies).

4.6.2 Where allowed/required, the investigator/institution may/should assign some or all the investigator's/institution's duties for investigational product(s) accountability at the trial site(s ) ) to an proper pharmacist or another suitable person who's under the oversight of their investigator/institution. .

4.6.3 The investigator/institution or a pharmacist or other appropriate person, who's given by the investigator/institution, should keep records of their item's delivery to the trial site, the inventory at the website, the usage by each topic, and also the yield to the sponsor or alternative disposition of unused product(s). These records must include dates, numbers, batch/serial numbers, expiration dates (if applicable), and the exceptional code numbers assigned to the investigational product(s) and trial subjects. Researchers should keep records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) obtained from the host.

4.6.4 The investigational product(s) ought to be kept as defined by the host (see 5.13.2 and 5.14.3) and in compliance with applicable regulatory requirement(s).

4.6.5 The investigator should ensure that the investigational product(s) are utilized only in compliance with the accepted protocol.

4.6.6 The investigator, or a person designated by the investigator/institution, must describe the proper use of the investigational product(s) to each subject and should check, at times appropriate for the trial, that each subject is following the directions correctly. If the trial is blinded, the investigator should promptly document and explain to the sponsor any early unblinding (e.g., accidental unblinding, unblinding because of a serious adverse event) of the investigational product(s).

4.8 Informed Consent of Trial Subjects

4.8.1 In obtaining and documenting informed consent, the investigator must comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles which have their source in the Declaration of Helsinki. Before the start of the trial, the investigator needs to have the IRB/IEC's composed approval/favourable view of this written informed consent form and any other written information to be offered to subjects.

4.8.2 The written informed consent form and any other written information to be given to subjects must be revised whenever important new information becomes available that may be pertinent to this subject's approval. Any revised written informed consent form, and written advice must get the IRB/IEC's approval/favourable view ahead of usage. The subject or the subject's legally acceptable representative ought to be informed in a timely fashion if new information becomes available that may be pertinent to the subject's willingness to continue participation in the trial. The communication of the information ought to be documented.

4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, even if the topic is not able to give informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written advice and also the approval/ favourable opinion by the IRB/IEC.

4.8.6 The language used in the written and oral information regarding the trial, including the written informed consent form, must be non-technical as functional and should be clear to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.

4.8.7 Before informed consent may be obtained, the investigator, or someone designated by the investigator, should offer the subject or the subject's legally acceptable representative ample time and opportunity to ask about details of the trial and also to choose whether or not to take part in the trial. All queries concerning the trial ought to be answered to the satisfaction of the topic or the subject's legally acceptable representative.

4.8.8 Before a subject's involvement in the analysis, the written informed consent form ought to be signed and dated by the topic or from the subject's legally appropriate agent, and from the man who conducted the informed consent discussion.

4.8.9 If a topic can't read or if a legally acceptable representative is not able to read, an impartial witness should be present throughout the entire informed consent discussion. Following the written informed consent form and any other written information to be given to subjects, will be read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject of involvement in the trial and, if capable of doing this, has signed and dated the informed consent form, the witness must sign and personally date the consent form. (b) The intention of the trial. If there's not any intended clinical benefit to the subject, the topic ought to be made aware of the (I) The alternative procedure(s) or course(s) of treatment which could be accessible to the matter, and their important potential benefits and hazards. (j) The reimbursement and/or therapy readily available to the subject at case of trial-related injury. (l) The anticipated expenses, if any, to the subject of participating in the trial. (n) The monitor(s), the auditor(s), the IRB/IEC, along with the regulatory authority(ies) will be granted direct entry to the subject's original medical records for verification of clinical trial processes and/or information, without violating the confidentiality of this topic, to the extent allowed by the applicable legislation and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access. (o) That records identifying the subject will be kept confidential and, to the extent allowed by regulations or laws, won't be made publicly accessible. If the outcomes of the trial have been published, the subject's identity will stay confidential. (p) The subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be pertinent to the subject's willingness to continue participation in the trial. (q) The individual (s) to contact for more information concerning the trial and the rights of trial subjects, and whom to contact in case of trial-related injury. (r) The foreseeable conditions and/or motives under the subject's involvement in the trial could be terminated. (s) The expected duration of the subject's involvement in the trial. (t) The approximate number of subjects included with the trial.

4.8.11 Prior to participation in the trial, the subject or the subject's legally acceptable representative should be given a copy of the signed and dated written informed consent form and any other written information supplied to the topics. During a subject's involvement in the trial, the subject or the subject's legally acceptable representative should get a copy of the signed and dated consent form updates and a copy of any amendments to the written information given to subjects.

4.8.12 When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be registered in the trial with the permission of the subject's legally acceptable representative (e.g., minors, or individuals with severe dementia), the subject ought to be informed about the trial to the extent compatible with the subject of comprehension and, if capable, the subject should sign and personally date the written informed consent.

4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial where there is not any anticipated direct clinical benefit to the subject), needs to be conducted in subjects who give consent and that sign and date the written informed consent form.

4.8.14 Non-therapeutic trials might be conducted in subjects with consent of a legally acceptable representative provided that the following requirements are fulfilled: (a) The aims of the trial can't be fulfilled by way of a trial in subjects that can provide informed consent. (c) The adverse influence on the subject's well-being is reduced and minimized. (d) The trial isn't prohibited by legislation. (e) The approval/favorable view of this IRB/IEC is especially sought on the inclusion of these topics, and the written approval/ favorable opinion covers this aspect. Topics in such trials must be particularly closely monitored and must be removed if they seem to be overly distressed.

4.8.15 In crisis situations, when prior permission of the subject isn't feasible, the permission of the subject's legally acceptable representative, if present, should be asked. When previous consent of the topic isn't feasible, along with the subject's legally acceptable representative isn't available, enrollment of this topic ought to require steps described in the protocol or elsewhere, with recorded approval/favorable opinion from the IRB/IEC, to safeguard the rights, security and well-being of this topic and also to guarantee compliance with applicable regulatory requirements. The subject or the subject's legally acceptable representative ought to be informed about the trial when possible and agree to continue along with additional approval as appropriate (see 4.8.10) ought to be asked.

4.9 Records and Reports

4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of their information reported to the host at the CRFs and in all necessary reports.

4.9.2 Data reported on the CRF, which are derived from source documents, ought to be in accordance with the source documents or the discrepancies should be clarified.

4.9.3 Any alteration or correction to a CRF ought to be dated, initialed, and explained (if necessary) and shouldn't obscure the original entry (i.e. an audit trail ought to be preserved ); that applies to both written and electronic changes or corrections (visit 5.18.4 (n)). Sponsors should provide advice to investigators or the researchers' designated representatives on making such corrections. Sponsors must have written procedures to ensure corrections or changes in CRFs created by sponsor's designated agents are recorded, are needed, and are backed by the investigator. The investigator must maintain records of the corrections and changes.

4.9.4 The investigator/institution must keep the trial documents as stated in Essential Documents for the Conduct of a Clinical Trial (see 8.) The investigator/institution must take steps to avoid accidental or premature destruction of those records.

4.9.5 Essential documents should be retained until at least two years following the final approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least two years have elapsed since the formal discontinuation of clinical development of the investigational item. These records should be kept for a longer period however if required by the relevant regulatory requirements or by having an arrangement with the host. It's the obligation of the host to notify the investigator/institution concerning when these documents no longer have to be kept (see 5.5.12).

4.9.6 The financial details of the trial ought to be recorded in an agreement between the host and the investigator/institution.

4.9.7 Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution must make readily available for direct access all requested trial-related documents.

4.10 Progress Reports

4.10.1 The investigator must submit written summaries of this trial status to the IRB/IEC yearly, or more often, if asked by the IRB/IEC.

4.10.2 The investigator should promptly provide written reports on the host, the IRB/IEC (see 3.3.8) and, where applicable, the institution on any changes significantly affecting the behavior of this trial, or raising the risk to subjects. The follow-up and immediate reports must identify subjects by unique code numbers assigned to the trial subjects instead of from the subjects' names, personal identification numbers, or addresses. The investigator must also comply with the applicable regulatory requirement(s) associated with the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) along with the IRB/IEC.

4.11.2 Adverse laboratory or events abnormalities identified in the protocol as critical to safety evaluations should be reported to the host in line with the coverage requirements and within the time intervals specified by the host in the protocol.

4.12 Premature Termination or Suspension of a Trial

In case the trial is prematurely terminated or suspended for any reason, the investigator/institution should immediately inform the trial issues, should guarantee proper treatment and follow-up for those issues, and, where required by the applicable regulatory requirement(s), should notify the regulatory authority(ies). Additionally:

4.12.1 If the investigator terminates or suspends a trial without prior agreement of the host, the investigator must inform the institution where applicable, and also the investigator/institution should immediately notify the host and the IRB/IEC, and should offer the sponsor along with the IRB/IEC a detailed written explanation of the termination or suspension.

4.12.2 If the sponsor terminates or suspends a trial (see 5.21), the investigator must immediately notify the institution where applicable along with the investigator/institution should immediately inform the IRB/IEC and supply the IRB/IEC a detailed written explanation of the termination or suspension.

4.12.3 When the IRB/IEC terminates or suspends its approval/favorable view of a trial (see 3.1.2 and 3.3.9), the investigator must inform the institution where applicable along with the investigator/institution should immediately notify the host and supply the sponsor with a detailed written explanation of the termination or suspension.

4.13 Final Report(s) by Investigator

Upon completion of the trial, the investigator, where relevant, should notify the institution; the investigator/institution must offer the IRB/IEC using a review of the trial's result, and the regulatory authority(ies) with any reports required.

5. SPONSOR

5.1 Quality Assurance and Quality Control

5.1.1 The host is responsible for implementing and maintaining quality assurance and quality management systems with written SOPs to make certain that trials are conducted and data are generated, documented (recorded), and documented according to the protocol, GCP, and the applicable regulatory requirement(s).

5.1.2 The host is responsible for securing agreement from all involved parties to ensure immediate access (see 1.21) to each of trial related websites, origin data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and review by domestic and international regulatory authorities.

5.1.3 Quality control ought to be applied to every point of data handling to make sure that all data are reliable and have been processed properly.

5.1.4 Agreements, created by the host with all the investigator/institution and some other parties involved with the clinical trial, must be in writing, within this protocol or in another arrangement.

5.2 Contract Research Organization (CRO)

5.2.1 A sponsor may transfer any or all the host's trial-related responsibilities and functions to a CRO, but the ultimate responsibility for its integrity and quality of the trial data always resides with the host. The CRO should apply quality assurance and quality management.

5.2.2 Any trial-related responsibility and function that's transferred to and assumed by a CRO ought to be given in writing.

5.2.3 Any trial-related responsibilities and functions not specifically transferred to and assumed by a CRO are retained by the host.

5.2.4 All references to a host within this guideline apply to a CRO to the extent that a CRO has assumed the trial related duties and functions of a host.

5.3 Medical Experience

The sponsor must designate suitably qualified medical staff that are easily available to counsel trial related health questions or issues. If needed, external advisor (s) can be made for this function.

5.4 Trial Design

5.4.1 The host must use qualified people (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, during all phases of their trial process, in designing the protocol and CRFs and preparing the investigations into assessing and preparing interim and final clinical trial reports.

5.5 Trial Management, Data Handling, and Record Keeping i.e. ICH GCP guidelines for clinical data management

5.5.1 The host must use appropriately qualified people to supervise the general conduct of this trial, to deal with the information, to confirm the information, to conduct the statistical analyses, and also to prepare the demo reports. The IDMC should have written operating procedures and keep written records of its meetings.

5.5.3 When using electronic trial data management and/or remote electronic trial information programs, the host needs to: (a) Ensure and document that the electronic data processing procedure(s) adheres to the sponsor's established requirements for completeness, accuracy and reliability, and consistent intended performance (i.e. identification ). (b) Maintains SOPs for utilizing such systems. (c) Make sure that these systems are intended to allow data changes in such a manner in which the data changes are documented and that there isn't any deletion of input data (i.e. keep an audit trail, information path, edit path ). (d) Keep a safety system which prevents unauthorized access into this information. (e) Keep a listing of those people that are licensed to produce information modifications (see 4.1.5 and 4.9.3). (g) Shield the blinding, if some (e.g. keep the data during data entry and processing system ).

5.5.4 When data are transformed during processing, then it must remain possible to evaluate the initial observations and data with the data that is processed.

5.5.5 The host must utilize an unambiguous subject identification code (visit 1.58) which enables identification of all of the information reported for every topic.

5.5.6 The host, along with other owners of all this information, should keep each the sponsor-specific necessary documents of interest to the trial (see 8).

5.5.7 The sponsor must maintain all sponsor-specific necessary files in conformance with all the applicable regulatory requirement(s) of this country(ies) in which the item is accepted, or at which the sponsor intends to submit an application for approval(s).

5.5.9 If the sponsor discontinues the clinical development of an investigational solution, the sponsor must notify all of the trial investigators/institutions and most of the regulatory authorities.

5.5.10 Any transfer of possession of this information must be reported on the proper authority(ies), according to the applicable regulatory requirement(s).

5.5.12 The sponsor must notify the investigator(s)/association(s) in writing of their requirement for document retention and should inform the investigator(s)/association(s) in writing whenever the trial associated documents are no more needed.

5.6 Investigator Choice

5.6.1 The host is responsible for picking the investigator(s)/association (s). Each investigator ought to be qualified by experience and training and should have sufficient funds (see 4.1, 4.2) to properly conduct the trial where the investigator is chosen. If business of some coordinating committee or choice of coordinating investigator(s) will be used in multicentre trials, their company and/or choice are the host's responsibility.

5.6.2 Before entering an agreement with an investigator/institution to perform a trial, the sponsor must offer the investigator(s)/association (s) using the routine and also an up-to-date Investigator's Brochure, and should provide adequate time for your investigator/institution to assess the protocol and also the info supplied.

5.6.3 The sponsor must obtain the investigator's/institution's arrangement: (a) to conduct the trial according to GCP, together with all the applicable regulatory requirement(s) (see 4.1.3), also with the protocol agreed to by the host and given approval/favorable remark by the IRB/IEC (see 4.5.1); (b) to comply with processes for information recording/reporting; (c) to allow tracking, auditing and review (see 4.1.4) and (d) to keep the trial associated essential files until the host informs the investigator/institution that these records are no longer required (see 4.9.4 along with also 5.5.12). The host and the investigator/institution need to sign the protocol, or an alternate file, to verify this arrangement.

5.7 Allocation of Duties

Before initiating a trial, the sponsor should define, establish, and devote most of of trial-related responsibilities and purposes.

5.8 Compensation to Subjects and Investigators

5.8.1 If required by the applicable regulatory requirement(s), the host must offer insurance or if indemnify (valid and fiscal policy ) that the investigator/the association against claims arising out of the trial, and except for claims that arise from prosecution and/or neglect.

5.8.2 The host's policies and procedures must deal with the expenses of treatment for trial issues in case of trial-related accidents in agreement with the applicable regulatory requirement(s).

5.8.3 When identification subjects receive reimbursement, the procedure and way of reimbursement must comply with applicable regulatory requirement(s).

5.9 Funding

The financial facets of the trial ought to be recorded in an agreement between the host and the investigator/institution.

5.10 Notification/Submission into Regulatory Authority(ies)

Prior to initiating the clinical investigation (s), the host (or the host and the investigator, even when necessary by the applicable regulatory requirement(s)) must submit any necessary program (s) into the proper authority(ies) for inspection, approval, and/or consent (as needed by the applicable regulatory requirement(s)) to commence the trial(s). Any notification/submission ought to be dated and include adequate information to recognize the routine. (b) A statement obtained in the IRB/IEC it is organized and functions in accordance with GCP and the applicable regulations and laws. (c) Documented IRB/IEC approval/favourable view and, when requested by the host, a recent backup of protocol, written informed consent form(s) and any other written information to be offered to areas, subject recruiting processes, and records associated with payments and reimbursement available to the topics, and some other files the IRB/IEC could have asked.

5.11.2 If the IRB/IEC states its approval/favourable view upon modification (s) in almost any feature of the trial, including alteration (s) of this protocol, written informed consent form and any other written information to be offered to areas, or other processes, the sponsor must obtain in the investigator/institution that a duplicate of the modification(s) created and the date approval/favourable remark was given from the IRB/IEC.

5.11.3 The sponsor must obtain in the investigator/institution dates and documentation of any IRB/IEC reapprovals/re-evaluations with hierarchical view, also of any withdrawals or suspensions of all approval/favourable view.

5.12 Information on Investigational Product(s) 5.12.1 When planning trials, the sponsor must ensure that adequate safety and efficacy information from nonclinical clinical or studies trials are readily available to support human vulnerability from the path, in the doses, for its length, and at the trial population to be analyzed.

5.12.2 The host must upgrade the Investigator's Brochure as important new information becomes available (see 7).

5.13 Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)

5.13.1 The host should ensure that the investigational product(s) (such as active comparator(s) and placebo( if appropriate ) is distinguished as appropriate for the stage of growth of the item (s), is fabricated according to any relevant GMP, and can be coded and tagged in a way that safeguards the blinding, if appropriate. Additionally, the labelling must comply with all applicable regulatory requirement(s).

5.13.2 The sponsor must determine, for the investigational product(s), decent storage temperatures, storage requirements (e.g. protection against mild ), storage times, reconstitution fluids and processes, and apparatus for product extract, if any. The host should notify all parties that are involved (e.g. tracks, researchers, pharmacistsand storage managers) of those determinations.

5.13.3 The investigational product(s) ought to be packed to avoid contamination and improper deterioration during storage and transport.

5.13.4 In clinical trials, the programming system to its investigational product(s) must incorporate a mechanism which allows rapid identification of their item (s) if a health crisis, but doesn't permit imperceptible fractures of this blinding.

5.13.5 If significant formulation changes are produced in the investigational or comparator product(s) throughout the course of clinical improvement, the outcomes of some further studies of the formulated product(s) (e.g. stability, dissolution rate, bioavailability) required to evaluate whether these changes could significantly alter the pharmacokinetic profile of this item ought to be available before using this newest formula in clinical trials.

5.14 Supplying and Handling Investigational Product(s)

5.14.1 The host is responsible for providing the investigator(s)/association (s) using all the investigational product(s ) ).

5.14.2 The host shouldn't provide an investigator/institution using the investigational product(s) before the host obtains all necessary documentation (e.g. approval/favorable view from IRB/IEC and regulatory authority(ies)).

5.14.3 The host must ensure that written procedures contain directions the investigator/institution must follow to the storage and handling of investigational product(s) for your trial and documentation . The processes should address decent and safe receipt, handling, storage, unloading, recovery of fresh product in issues, and yield of unused investigational product(s) to the host (or other disposition if approved by the host and in accordance with all the applicable regulatory requirement(s)).

5.14.4 The host needs to: (a) guarantee timely delivery of investigational product(s) into this investigator(s). (b) Keep records that document dispatch, receipt, disposition, reunite, and also destruction of this investigational product(s) (see 8). (c) Maintain a method for regaining investigational products and recording that this recovery (e.g. for deficient product remember, recover after trial completion( expired merchandise recover ).

5.14.5 The host needs to: (a) Take action to make certain that the investigational product(s) are steady over the length of usage. (b) Maintain adequate quantities of the investigational product(s) utilized from the trials to reconfirm specifications, so should it be necessary, and keep records of batch sample investigations and attributes. To the degree equilibrium allows, samples must be kept either before the investigations of the trial data will be complete or as needed by the applicable regulatory requirement(s), whichever reflects the longer retention interval.

5.15 Record Access

5.15.1 The host must ensure it is given in the protocol or other written agreement which the investigator(s)/association (s) offer immediate access to source data/documents such as trial- related observation, Tests, IRB/IEC inspection, and regulatory review.

5.15.2 The host must verify that every subject has agreed, in writing, to guide accessibility to their own first medical records to get trial-related observation, audit, IRB/IEC inspection, and regulatory scrutiny.

5.16.2 The sponsor must immediately notify all concerned investigator(s)/association (s) and the regulatory authority(ies) of findings which could affect negatively the security of topics, affect the behavior of this trial, or change the IRB/IEC's approval/favourable view to keep the test.

5.17.3 The sponsor must submit to the regulatory authority(ies) all security upgrades and periodic reports, and according to applicable regulatory requirement(s).

5.18 Tracking

5.18.1 Purpose

The functions of trial monitoring are to confirm: (a) The rights and also well-being of individual subjects are protected. (c) The conduct of the offense will be in accordance with the approved protocol/amendment(s), with GCP, along with all the applicable regulatory requirement(s). (b ) Monitors must be suitably trained, and ought to possess the clinical or scientific knowledge required to track the trial satisfactorily. A track's qualifications must be recorded.

5.18.3 Extent and Nature of Monitoring

The host should ensure that the trials have been adequately tracked. The sponsor must determine the right scope and nature of observation. The conclusion of the scope and nature of monitoring should be determined by factors like the purpose, function, style, complexity, blinding, size, and endpoints of this trial. Generally speaking there's a demand for onsite observation, before, during, and after the trialhowever in extraordinary circumstances the host may decide that central observation in combination with processes such as researchers' meetings and training, and comprehensive written advice can assure proper conduct of the trial in agreement with GCP. Statistically controlled sampling could be an acceptable way of selecting the information to be checked.

5.18.4 Monitor's Responsibilities

The track (s) in compliance with the host's requirements need to make sure that the trial will be conducted and recorded properly by executing the following actions when relevant and essential to this trial and the crime website: (a) Acting as the major field of communication between the host and the investigator. (b) Verifying that the investigator has sufficient qualifications and tools (see 4.1, 4.2, 5.6) and stay adequate throughout the trial period, which facilities, such as labs and equipment, and employees, are sufficient to safely and properly conduct the trial and stay adequate throughout the trial period. (ii) The investigational product(s) are provided exclusively to subjects that are qualified for it and in the protocol given dose(s). (iii) That matters are supplied with necessary education on correctly using, managing, storing, and returning to the investigational product(s). (iv) The reception, use, and yield of this investigational product(s) in the trial sites are regulated and recorded adequately. (v) The disposition of unused investigational product(s) in the trial sites complies with all applicable regulatory requirement(s) and can be in accord with the sponsor. (e) Verifying that written informed consent was obtained prior to each subject's involvement in this trial. (f) Ensuring that the investigator gets the current Investigator's brochure, all records, and all of the trial provides required to conduct the trial properly and also to comply with the applicable regulatory requirement(s). (h) Verifying that the investigator and the investigator's trial staff are currently still doing the given trial purposes, in accord with the protocol along with another written agreement between the host and the investigator/institution, also haven't assigned the functions to unauthorized people. (I) Verifying that the investigator will be enroling only qualified subjects. (j) Reporting the matter recruitment rate. (k) Verifying that source files and other trial documents are true, complete, retained up-to-date and preserved. (Id) Verifying that the investigator provides all of the essential documents, notifications, applications, and admissions, and these records are accurate, comprehensive, timely, legible, dated, and also establish that the trial. (m) Assessing the accuracy and completeness of the CRF entries, source files and other trial-related documents contrary to each other. The monitor especially should confirm that: (I) The information required by the protocol have been reported right about the CRFs and therefore are in accordance with the source files. (ii) Any dose or treatment alterations are well documented for all the trial issues. (iii) Adverse events, concomitant medications and inter-current disorders are reported with regard to the routine in the CRFs. (iv) Visits the subjects don't create, tests which aren't conducted, and tests which aren't performed are reported as such on the CRFs. (n) Informing the inheritance of any CRF entrance mistake, omission, or illegibility. The monitor must ensure that proper adjustments, additions, or deletions are made, obsolete, clarified (if needed ), and initialed by the investigator or from a part of the investigator's trial staff who's licensed to first CRF modifications to your investigator. This consent ought to be documented. (o) Deciding whether adverse events (AEs) are reported over the time intervals required by GCP, the protocol, the IRB/IEC, the host, as well as the applicable regulatory requirement(s). (de) Deciding if the investigator is keeping the vital files (see 8. )

5.18.5 Monitoring Procedures

The track (s) must occur after the host's established written SOPs in addition to those processes which are given by the host for tracking a particular trial.

5.18.6 Monitoring Report

(a) The screen must submit an official report to the host after every trial-site see or trial-related communication. (b) Reports must include the date, website, title of the track, and title of the investigator or other person (s) contacted. (c) Reports must include a summary of the track reviewed along with the track's statements regarding the substantial findings/facts, deviations and deficiencies, decisions and actions taken or to be obtained and/or activities recommended to procure compliance. (d) The follow-up and review of this observation report with all the host ought to be recorded by the host designated agent.

5.19 Audit

When Patrons Execute audits, as a Part of Executing quality assurance, they Ought to Think about: 5.19.1 Purpose

The purpose of a host's audit, that will Be independent of and different from regular monitoring or quality control purposes, is to assess trial behavior and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

5.19.2 Selection and Qualification of Auditors

(a) The sponsor must appoint individuals, that are independent of their clinical trials/systems, to run research. (b) The sponsor should make sure that the auditors are qualified by experience and training to conduct audits properly. An auditor's qualifications must be recorded.

5.19.3 Auditing Procedures

(a) The sponsor should ensure that the auditing of clinical trials/systems is conducted with respect to the sponsor's written procedures about which to audit, the way to study, the frequency of analysis, as well as the shape and content of reports. (b) The host's audit program and processes for a trial should be directed by the value of the trial to admissions to regulatory authorities, the amount of subjects from the trial, and the form and complexity of the trial, and the amount of threats to the trial issues, along with also any identified issue (s). (c) The findings and observations of the auditor(s) ought to be documented. (d) To maintain the freedom and importance of the audit function, the regulatory authority(ies) shouldn't routinely ask the audit accounts. Regulatory authority(ies) could find entry to an audit report on a case by case basis if signs of critical GCP non-compliance is present, or even in the course of legal proceeding. (e) If required by applicable law or regulation, the host must offer an audit certification.

5.20 Noncompliance

5.20.1 Noncompliance with all the protocol, SOPs, GCP, or relevant regulatory requirement(s) with an investigator/institution, or from member(s)) of their host's staff should result in prompt action from the host to secure compliance.

5.20.2 in the event the observation and/or auditing describes long-term or serious noncompliance on the part of an investigator/institution, then the host must terminate the employee's /institution's involvement at the trial. Once an investigator's/institution's participation is terminated due to noncompliance, the host must notify immediately the regulatory authority(ies).

5.21 Premature Termination or Suspension of a Trial

When a trial is prematurely terminated or suspended, then the host should immediately inform the investigators/institutions, along with the regulatory authority(ies) of their conclusion or suspension and the reason(s) for the termination or suspension. The IRB/IEC also needs to be advised promptly and given the rationale (s) for the termination or suspension from the host or from the investigator/institution, according to the applicable regulatory requirement(s).

5.22 Clinical Trial/Study Reports When the trial has been completed or terminated, the sponsor should make certain that the clinical trial accounts are prepared and supplied to the regulatory agency(ies) according to the applicable regulatory requirement(s). The host must also make sure that the clinical trial reports in advertising programs meet the criteria of this ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports reveal that abbreviated study reports may be appropriate in certain instances.)

5.23 Multicentre Trials For multicentre trials, the sponsor must make sure that:

5.23.1 All researchers conduct this trial from strict compliance with the protocol agreed to by the host and, if necessary, from the regulatory authority(ies), also awarded approval/favorable remark by the IRB/IEC.

5.23.2 The CRFs are made to capture the essential information at all multicentre trial websites. For those researchers that are collecting further information, supplemental CRFs must also be supplied that are intended to capture the extra data.

5.23.3 The duties of coordinating investigator(s) along with another participating investigators are recorded before the beginning of the trial.

5.23.4 All researchers are given directions on after the protocol, to complying with a uniform set of criteria for the evaluation of clinical and laboratory findings, and on finishing the CRFs.

6. But site specific advice might be given on separate protocol page(s), or handled in another agreement, and a few of the info listed below can be included in other protocol referenced documents, including an Investigator's Brochure. Any modification (s) must also bear the amendment number(s) and date(s).

6.1.3 Name and name of the individual (s) authorized to sign the protocol and the protocol change (s) for your host.

6.1.4 Name, name, address, and phone number(s) of their host's medical practitioner (or dentist when appropriate) for the offense.

6.1.5 Name and name of the investigator(s)) who is/are responsible for conducting the trial, along with the address and phone number(s) of the trial site(s).

6.1.6 Name, name, address, and phone number(s)) of the qualified physician (if appropriate), who's accountable for many trial-site associated medical (or dental) decisions (if other than investigator).

6.1.7 Title (s) and address(es) of the clinical laboratory(ies) and other technical or medical section (s) and/or associations involved with the trial.

6.2 Background Information

6.2.1 Title and description of the investigational product(s).

6.2.2 A list of findings in nonclinical studies that potentially have clinical significance and from clinical trials which are linked to this trial.

6.2.3 Summary of the known and possible risks and advantages, if any, to human subjects.

6.2.5 An announcement that the trial will be run in accordance with the protocol, GCP and the applicable regulatory requirement(s).

6.2.6 Description of the population to be researched.

6.2.7 References to literature and information which are related to the trial, which provide background for your trial.

6.3 Trial Objectives and Purpose

A comprehensive outline of the goals and the objectives of the trial.

6.4 Trial Design

The scientific integrity of this trial and the trustworthiness of the information from the trial depend considerably on the trial layout. A description of the trial design, must contain:

6.4.1 A particular statement of the principal endpoints and the secondary endpoints, if any, to be measured throughout the trial.

6.4.2 An outline of this type/design of trial must be performed (e.g. double sided, placebo-controlled( parallel design) and a schematic diagram of trial design, processes and phases.

6.4.3 A description of the measures required to minimize/avoid prejudice, such as: (a) Randomization.

6.4.4 An outline of the trial treatment(s) and the dose and dose regimen of the investigational product(s).

6.4.5 The expected duration of subject participation, and a description of this order and duration of all trial periods, such as followup, if any.

6.4.6 A description of the"stopping rules" or"discontinuation criteria" for different topics, elements of trial and complete trial.

6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no previous written or electronic record of data), also also to be regarded as source data. (b) The type and timing of this information to be collected for withdrawn subjects. (d) The followup to subjects withdrawn from investigational product treatment/trial therapy.

6.6 Treatment of Topics

6.6.1 The remedy (s) has to be treated, including the name(s) of the item (s), the dose(s), the dosing schedule(s), the route/mode(s) of government, and the treatment period(s), for instance, follow-up interval (s) for subjects for each investigational product treatment/trial therapy group/arm of this trial.

6.6.2 Medicine (s)/treatment(s) permitted (including rescue medication) and not allowed before or throughout the trial.

6.7.2 Methods and timing for assessing, recording, and assessing of efficiency parameters. 6.8.2 The timing and methods for assessing, recording, and assessing safety parameters. 6.8.4 The kind and length of the followup of subjects after adverse events.
6.9 Statistics

6.9.1 A number of the statistical techniques to be employed, including timing of any planned interim analysis(ses).

6.9.2 the amount of subjects planned to be registered.
6.9.3 the degree of importance to be utilized. 6.9.4 Criteria for the conclusion of this trial.

6.9.6 Procedures for reporting any deviation(s) from the original statistical plan (any form (s) from the original statistical plan ought to be clarified and justified from protocol or in the last report( as appropriate).

6.9.7 The choice of topics must be included in the investigations (e.g. all distinct subjects, all dosed subjects, all eligible subjects, evaluable subjects).

6.10 Direct Access to Source Data/Documents The host must ensure it is given in the protocol or other written agreement that the investigator(s)/association (s) will allow trial-related tracking, audits,

IRB/IEC inspection, and regulatory review (s), providing immediate access to supply data/documents.

IRB/IEC inspection, and regulatory review (s), providing immediate access to supply data/documents. 6.13 Data Handling and Record Keeping

6.14 Financing and Insurance Coverage Financing and insurance if not addressed in a separate arrangement.

6.15 Publication Policy Publication policy, if not handled in another agreement. 6.16 Supplements (NOTE: As the protocol along with the clinical trial/study document are closely linked, additional relevant information is found at the ICH Guideline for Structure and Content of Clinical Study Reports.)

INVESTIGATOR'S BROCHURE

7.1 Introduction

The Investigator's Brochure (IB) is a set of the clinical and nonclinical data on the investigational product(s) which relate to the analysis of the merchandise (s) in human subjects. Its objective is to deliver the researchers and others involved with the trial using all the data to facilitate their comprehension of the rationale behind, and their compliance with, several important features of this protocol, like the dosage, dosage frequency/interval, techniques of management: and security monitoring processes. The IB also gives insight to help the clinical direction of their research subjects throughout the course of this clinical trial. The info ought to be displayed in a concise, simple, objective, balanced, and also non-promotional type that allows an individual clinician, or possible investigator, to comprehend it and create his unbiased risk-benefit evaluation of the appropriateness of the planned trial. Because of this a medically qualified individual should normally take part in the screening of an IB, however, the contents of the IB must be accepted by the areas that created the described information. This guideline delineates the minimal information which needs to be contained within an IB and gives tips for its design. It's anticipated that the kind and degree of information available will change with the period of growth of the investigational item. If the investigational product is promoted and its pharmacology is broadly known by medical professionals, a comprehensive IB might not be vital. Where permitted by law enforcement, a fundamental product information booklet, package leaflet, or data could possibly be an proper choice, given that it comprises comprehensive, current, and comprehensive advice on all parts of the investigational product which may be of significance to this investigator. If a promoted product has been analyzed for a new usage (i.e., a brand new sign ), an IB unique to this new use ought to be ready. The IB must be evaluated at least annually and revised as required in accordance with a host's written procedures. More regular revision could be appropriate based on the phase of evolution and the creation of relevant new info. Nonetheless, in accordance with Good Clinical Nutrition, pertinent new information might be so significant that it needs to be conveyed to the researchers, and maybe into the Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) or regulatory governments before it's contained in a revised IB. Usually, the host is responsible for ensuring an up- to-date IB is made accessible for the investigator(s) and the researchers are responsible for supplying the up-to-date IB into the accountable IRBs/IECs. In the instance of a worker sponsored trial, then the sponsor-investigator must find out if a booklet is available in the industrial maker. If the investigational product is supplied by this sponsor-investigator, then they must offer the essential info to the trial staff. In scenarios when planning of a proper IB is impractical, the sponsor-investigator must supply, as a replacement, an enlarged background information element in the trial procedure which includes the minimal present data described within this principle.

7.2 General Considerations the IB should comprise:

7.2.1 Title Page

This ought to offer the host's name, the identification of every investigational product (i.e., study number, compound or accepted generic title, and transaction name(s) where legally permissible and desired by the host), along with also the launch date. It's also suggested an edition number, and a reference to this date and number of the variation that it supersedes, be supplied. A good instance is provided in Appendix 1.

7.2.2 Confidentiality Statement

The sponsor might desire to incorporate a statement instructing the investigator/recipients to take care of the IB as a private record for the only information and usage of this investigator's team along with the IRB/IEC.

7.3 Contents of the Investigator's Brochure

The IB should include these segments, each with literature references where appropriate: 7.3.1 Table of Contents An illustration of the Table of Contents is provided at Appendix 2

7.3.2 Summary

A short summary (preferably not exceeding two pages) ought to be granted, highlighting the substantial physical, chemicaland pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical data available that's pertinent to this point of clinical development of the investigational item.

7.3.3 Introduction

A short introductory statement ought to be provided that includes the compound name (and generic and trade name(s) when accepted ) of the investigational product(s), all active components, the investigational product (s) pharmacological category and its expected location in this category (e.g. benefits ), the justification for performing study using an investigational product(s), as well as the expected prophylactic, therapeutic, or diagnostic sign (s). At length, the introductory statement must offer the overall strategy to be followed in assessing the investigational item.

7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation

A description ought to be given of this investigational product material (s) (such as the compound or structural formulation (e), plus a succinct summary ought to be due to the applicable physical, chemical, and pharmaceutical properties. To allow proper security measures to be obtained in the duration of this trial, an outline of the formula (s) to be utilized, such as excipients, ought to be supplied and justified when clinically applicable. Directions to the storage and management of this dose form(s) must also be granted. Any similarities with other substances should be noted.

ICH GCP E6 R2
On Mar 8, 2018, the FDA updated ICH E6(R1) with E6(R2) Good Clinical Practice: Integrated Addendum

to ICH E6(R1). Here are some noticeable changes and how they will impact the industry.

1. One of the key improvement is the new definition of a licensed copy of a situation report form (1.11). This improved definition states:"[a] newspaper or digital copy of the first document that's been confirmed (e.g., with a dated signature) or was generated via a validated procedure to make an specific copy using all the very exact features and data as the first." This improvement helps better explain how to ascertain the validity of trial-related documents duplicates, such as source files.

Additionally, the definition of tracking (1.38) has been broadened to incorporate the observation program, which can be described as "[an] outline of these methods, duties, and demands for tracking the trial." The updated definition doesn't call for the monitoring plan for a standalone file, but leaves an expectation that a proper plan is different. In addition, the observation report (1.39) definition has expanded to add "[results] of almost virtually any centralized monitoring also needs to be noted." Nonetheless many patrons now include concentrated monitoring as part of the general monitoring procedures because if this monitoring doesn't happen through a formal onsite observation trip, it might not be satisfactorily documented. The expanded definition will guarantee that patrons produce an account to demonstrate the concentrated monitoring that has been performed.

A number of improvements have been suggested to the Investigator department (part 4). for one, part 4.2.6 has been updated to say:"[in] the event the investigator/institution keeps the assistance of any party to do research jobs, they ought to ensure this celebration is qualified to execute these research jobs and should employ procedures to guarantee the integrity of their analysis jobs completed and any information created." These qualifications and oversight responsibilities weren't explicitly mentioned in the preceding edition, however, clinical trial sponsors anticipated researchers to implicitly stick to those guidelines. The upgraded statements today represent FDA's well- established advice on the pupil's supervisory responsibilities.

The definition of sudden adverse drug response (1.60) currently contains a brand new definition titled "identification of automatic systems" (1.60.1). But, there doesn't appear to be an evident connection between the definition of adverse medication reactions and this definition--"[a] practice of establishing and recording the specified prerequisites of a computerized system may be always fulfilled. An logical step will be to create this new PC validation definition 1.61 then renumber the past two definitions from the Glossary (vulnerable themes and well-being) into 1.62 and 1.63, respectively, and which could possibly be performed when the last record is published.

Part 5.18.6 (Tracking Report) contains a new section (e) that says "[tracking] results should be supplied to the host (such as proper management and personnel accountable for trial and website supervision) in a timely fashion for review and follow up as indicated. Outcomes of monitoring activities must be recorded in enough detail to permit confirmation of compliance with the observation program."

Section 5, Sponsors, comprises substantial adjustments and enhancements. The draft comprised a significant new segment 5.0 (Quality Management), where the notions of quality management, with a focus on risk management, are incorporated into the host's responsibilities. Though risk management procedures are well-known in the healthcare care sector, they have yet to be extensively applied to the preparation and execution of clinical trials. The upgrade will call for clinical trials patrons to start obtaining the essential instruction and tools to establish those principles. Two helpful overall resources include ICH Q9, Quality Risk Management, that will be a high level summary of risk management fundamentals, along with ISO 14971, Application of Risk Management to Medical Devices, a worldwide security standard related to all phases in the life span of a medical apparatus, for example its early growth. While these two records are tailored toward producing hazard management, they can provide useful information related to clinical trial preparation too. Table 1 lists the entire text of this suggested quality control department.

The draft creates no suggested modifications to the Department 3, Institutional Overview Board/Independent Ethics Committee.

In section 4.9, Records and Reports, a fresh introductory announcement (4.9.0) was added which says "[the] investigator must keep accurate and adequate source records and trial documents which have all applicable observations on each of the website's trial topics. Source data ought to be conducive, legible, contemporaneous, first, authentic, and complete. Changes to supply data ought to be traceable, shouldn't obscure the original entrance, and ought to be clarified if required (e.g., through an audit trail)."

Regular review of data that is submitted. Identification of lost information, conflicting data, information outliers, or sudden deficiency of variability and protocol deviations which could possibly be indicative of significant or systematic mistakes in data collection and reporting in a website or through sites, or might be indicative of possible data manipulation or data integrity issues. Utilization of statistical investigations to identify information trends like the consistency and range of information within and across websites. Evaluation of website features and performance metrics. Choice of websites and/or procedures are targeted onsite monitoring.

The previous modification increases section 8.1 (Introduction) the following improvements:"[the] host and investigator/institution need to keep a listing of the place(s) of the individual key documents.’ The storage method (no matter the media used) need to supply for record identification, research, and recovery. Based upon the actions being completed, individual trials will call for additional files not particularly mentioned in the vital document listing. The host or investigator/institution should incorporate these within this trial master document. The host should make sure that the investigator has command of continuous access to the CRF information reported to the host. The host shouldn't have management of these data. When a backup is utilized to replace a first record, the backup should meet the prerequisites for certified copies.

The draft includes several alterations that address fluctuations from the scale, sophistication, and expense of clinical trials because the former version was embraced. Since clinical research workers have access to innovative technologies and risk management procedures that might raise efficacy and concentrate on important clinical research actions, E6 has been amended to promote the implementation of advanced and more effective methods to clinical trial design, conduct, supervision, documenting, and reporting, while still ensuring human subject security and information integrity are preserved. Additionally, the upgrade includes changes to describe criteria on electronic documents and documents that are essential. In the end, the new record is intended to assist clinical research protect human areas, keep data integrity and quality, and correctly record trial benefits. This guide will emphasize the vital changes that impact research professionals. These alterations are anticipated to be assessed and approved inside ICH and then integrated into the E6 record from the end of 2016.

Revisions to the segment on tracking (5.18) reflect a stronger dependence on risk-based observation. The revisions include the components in the FDA's recent advice on risk-based observation. These alterations have been noted in part 5.18.3 (Extent and Nature of Monitoring) and comprise these improvements:"The host must create a systematic, guaranteed, risk-based method of tracking clinical trials. The flexibility at the scope and character of monitoring described in this section is meant to enable diverse approaches that enhance the efficacy and efficiency of observation. A combo of onsite and concentrated monitoring actions could be proper. The sponsor must file the rationale behind the selected observation approach (e.g., from the monitoring program )."

Part 5.20 (Noncompliance) comes with an augmentation which reflects regulatory ability expectations which patrons will try to recognize the root of non-compliance at a strong way and execute effective corrective and preventative strategies. The new segment (5.20.1) says:"[when] important noncompliance is found, the host must execute a root cause investigation and execute appropriate corrective and preventative actions. When required by law or regulation, then the host must notify the regulatory authority(ies) whenever the noncompliance is a severe violation of the trial procedure or GCP."

The draft also suggested a new segment 5.18.7 (Monitoring Plan) that says:"The host must develop a monitoring program that's tailored to the particular human subject security and information integrity risks of this trial. The program must describe the monitoring approach, the monitoring responsibilities of all of the parties involved, the a variety of tracking methods to be utilized, and the justification for their usage. The program should also highlight the observation of essential data and procedures. Particular care ought to be given to all these aspects which aren't regular clinical practice which need further training. The monitoring program should reference the related policies and processes."

Section 5.2, Contract Research Organization (CRO)also comprises two suggested changes that need sponsors to have a more active part in tackling their CROs. Section 5.2.1 was improved with the following announcement:"[the] host must ensure oversight of almost any trial-related responsibilities and works performed on its own behalf." Section 5.2.2 was improved with the following announcement:"[the] host must record approval of some subcontracting of all trial-related responsibilities and works with a CRO." This is very related to small and startup manufacturers which rely heavily upon CROs for handling all or most trial-related pursuits. The modifications state that patrons might not abdicate this duty and have to have a more active part in their supervision of the CROs.

Additionally, the ICH Upgrades underline the usage of centralized tracking as a vital approach to match and lower the frequency or extent of onsite observation.

Section 5.5.3 (b) is modified to describe expectations for normal operating procedures (SOPs) for digital data systems and handling. The proposed language says"[the] SOPs must pay for system installation, setup, and usage. The SOPs must explain system identification and performance testing, information collection and handling, program maintenance and system safety measures, shift management, information backup, recovery, contingency planning, and decommissioning. The obligations of the sponsor, employee, as well as other parties connected to the usage of those unmanned systems ought to be apparent, and the consumers must be supplied with instruction in the usage of their systems." The draft also comes with a brand new announcement 5.5.3 (h), which says that patrons are predicted to"[ensure] that the integrity of their information containing any information that explain the context, content, and arrangement of their information." This inclusion is very important whenever making modifications to the automatic systems, including software upgrades or migration of information.

Principal Investigator Training - Role of Principal Investigator in Clinical Research

Principal Investigator

Principal Investigator Training - Advanced Principal Investigator Physician Certification (APIPC)™

Are you a physician passionate about advancing medical knowledge through clinical research? Do you aspire to lead clinical trials and contribute to the development of new treatments? If so, then Principal Investigator (PI) training and certification can be your gateway to a rewarding career at the forefront of medical discovery.

What is a Principal Investigator?

A Principal Investigator is a physician who oversees all aspects of a clinical trial. They are responsible for the scientific integrity of the study, ensuring participant safety, and adherence to regulatory guidelines, including those set by ICH-GCP. PIs play a crucial role in ensuring the success of clinical trials and ultimately, the development of life-saving therapies.

Why Consider PI Training and Certification?

While formal PI training is not always mandatory, it equips physicians with the necessary knowledge and skills to excel in this demanding role. Here are some compelling reasons to consider PI training and certification:

• Enhanced Knowledge: Training programs delve deeper into the intricacies of clinical trial design, regulatory compliance, Good Clinical Practice (GCP), and ethical considerations.

• Increased Credibility: Completing a program and earning an Advanced Principal Investigator Physician Certification (APIPC™) demonstrates your commitment to excellence and expertise in clinical research. This can make you a more attractive candidate for research sponsors and pharmaceutical companies seeking qualified investigators for their trials.

• Improved Patient Care: By gaining a thorough understanding of research protocols and ethical considerations, PIs can ensure the well-being of study participants and contribute to the development of safer and more effective treatments.

• Career Advancement: As the demand for qualified clinical investigators continues to rise, PI training and certification can open doors to exciting career opportunities in academia, research institutions, and the pharmaceutical industry.

What Does PI Training Cover?

PI training programs typically cover a broad range of topics, including:

• Clinical trial design and methodology

• Regulatory requirements for clinical research (e.g., FDA regulations, ICH-GCP guidelines)

• Ethical considerations in clinical research informed consent, participant protection)

• Data management and statistical analysis

• Budget development and financial management

• Effective communication and collaboration with research sponsors, CROs, and research teams

PI Training Options: Online Convenience with CCRPS

The good news is that you can invest in your PI development through online training programs! The Clinical Research Champions (CCRPS) offers a comprehensive online principal investigator training program designed for physicians seeking advanced review and understanding of essential PI roles. Consider exploring the Medical Monitor Certification as well, which is part of the comprehensive suite of courses offered.

Benefits of CCRPS PI Training:

• Accredited Training: CCRPS courses are accredited by the Accreditation Council for Clinical Research & Education (ACCRE) and jointly accredited with PIMED by the American Medical Association (AMA) to provide 17.5 CME credits for physicians.

• Enhanced Credibility: The program incorporates ICH GCP and E6 certification, recognized through meeting Transcelerate BioPharma requirements, further bolstering your credentials.

• Practical Knowledge: While PI certification through examination isn't mandatory for conducting trials, CCRPS training equips you with the knowledge needed for initial PI roles and paves the way for future certification (which often requires 3,000 hours of PI experience).

Career Advancement: Many physicians utilize CCRPS training to advance their existing PI roles and gain the skills and confidence to function as certified principal investigators. Consider exploring additional certifications such as the Advanced Clinical Research Project Manager Certification to further enhance your career trajectory.

By investing in PI training and potentially pursuing the APIPC™ certification, you're making a strategic move to become a leader in clinical research. CCRPS' online program offers a convenient and accredited way to acquire the knowledge and skills needed to excel in this rewarding field. Take charge of your career and contribute to groundbreaking medical advancements. Enroll in CCRPS PI training today!

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The benefits of the PI training course is to improving efficiency, learning about multiple similar trials, and getting the fund of knowledge needed to improve quality, teamwork, and data.

• While certification is not required for PIs to conduct trials, PI-sponsors and organization sponsors can show sponsors that PIs receive therapeutic-specific education and content-backed certification.

• Most broadly, training can be another quality initiative to prevent trial errors. We teach in-depth with modules covering things like developing inclusion-exclusion criteria, writing protocols, etc. Our focus is on including multiple practical references, applications, and perspectives such that PIs can feel more comfortable making critical decisions in the trial.

Know that non-MDs/PharmDs can be a principal investigator if a physician is a co principal investigator. As a PI, you can take training courses to improve efficiency and apply it through trial examples. The course covers topics such as developing inclusion-exclusion criteria and writing protocols which will prevent errors in future research projects

The benefits of the PI training course is to improving efficiency, learning about multiple similar trials, and getting the fund of knowledge needed to improve quality, teamwork, and data.

• While certification is not required for PIs to conduct trials, PI-sponsors and organization sponsors can show sponsors that PIs receive therapeutic-specific education and content-backed certification.

• Most broadly, training can be another quality initiative to prevent trial errors. We teach in-depth with modules covering things like developing inclusion-exclusion criteria, writing protocols, etc. Our focus is on including multiple practical references, applications, and perspectives such that PIs can feel more comfortable making critical decisions in the trial.

Know that non-MDs/PharmDs can be a principal investigator if a physician is a co principal investigator.

Principal Investigator Definition

A Principal Investigator in Research is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

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What Is A Principal Investigator

PI principal investigator is responsible for the preparation, conduct, and completion of the research or project being funded by a grant or sponsor. This is increased by having additional educational training such as through CCRPS’s Advanced Principal Investigator Physician Certification (APIPC)™.

Principal Investigator Salary ranges heavily based on the physicians ability to manage both trials and their typical clinical caseload. While most MDs have a high salary from their career, running a trial can add between $37,000 to $279,000 as their additional clinical research principal investigator salary. Although this can be demanding, the reward of being able to offer new therapeutic advances to their patients is well worth it. Co Principal Investigator is a second physician helping assist in these duties usually for larger trials.

NIH principal investigator funding is best obtained by following and reviewing all of the resources available in the toolkit linked prior. See how to become a principal investigator at the NIH here.

Principal Investigator roles and responsibilities in clinical research

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What does a PI do in the clinical research process?

These are covered in the ICH GCP guidelines and are summarized below (Feehan, 2020):

Role of Principal Investigator in Clinical Research: Anyone qualified by training to run the trial; a physician or dentist must be listed as a sub-investigator if the principal investigator is not a physician

TO: Hire and train qualified individuals to run the trial AND

Protect subject safety: Protect subjects from harm, Keep track of drugs and distribute only as specified in the protocol, Obtain informed consent, Ensure IRB approval, Keep careful records and maintain them for as long as the protocol dictates or at least 2 years AND

Report: Progress, safety, financial, and a final report to the study sponsor, Adverse events; serious adverse events must be reported immediately, Update financial disclosures if any circumstances change during the study AND

Follow Form 1572: Strictly adhere to the protocol, Directly supervise the study and take responsibility for study staff, Inform subjects of experimental nature of the drug products, Report adverse events and stay updated on the investigational brochure, Maintain records, Ensure IRB compliance AND

Prepare for FDA inspections: Ensure all records are complete and easily accessible by FDA, Send a written response within 15 business days if any violations are found AND

Avoid violations: Read all communications from the IRB, Hire experienced staff and verify their credentials, Train staff regularly, Check for conflicts of interest/financial disclosures regularly, Write efficient protocols or reduce inefficiencies or confusing portions of the protocol, Keep regulatory binders up to date and conduct continuing reviews, Meet with the team regularly, Conduct several dry runs to ensure the study will run smoothly, Regularly check data processes

Download the FDA Principal Investigator roles and responsibilities powerpoint here.

Principal Investigator Training 

The responsibility of conducting successful clinical trial lies upon the shoulders of a Principal Investigator. This successful completion of the trials is accomplished by major duties of an Investigator who is responsible for the delegation of duties to other staff members as well as the safety, protection of rights and well-being of the volunteers.

The research volunteers have the right to know about the study that either it is conducted for research purpose or not. Moreover, any alterations in study protocol must be appropriately mentioned to the volunteers and giving them the right to either continue or quit the studies. Providing accurate and appropriate data, informing the ethical committees about the issues related to research site, issues related to adverse effects of drug are the key responsibilities of the Investigator.

To perform all these crucial responsibilities an investigator must pass through the training and evaluation to improve the standards of trials.
The training of PI’s is categorized into different modules so that with the passage of each module all the responsibilities and documents become clear.

PI Course Syllabus

Introduction

• Accreditation Statement

• CME Handout - How to Obtain 17.5 CME Credits through AMA/ACCME

• Principal Investigator Toolkit

• How to Effectively Use this Course

• The Role Of The Principal Investigator

  • Principal Investigators Roles, Checklists, & GCP Guidelines

  • Principal Investigators Reporting Responsibilities for AEs and SAEs

  • FDA Form 1572 - Part 1

  • FDA Form 1572 - Part 2

  • Investigator Initiated Multi-Center Trials

  • Investigational Product Storage and Dispensing

  • Investigational Product Accountability in Clinical Trials

• Clinical Trial Design & Protocol

  • Phases of Clinical Trials

  • Designs of Clinical Trials

  • Randomized Controlled Trials

  • Institutional Review Board (IRB)

  • The Clinical Trial Protocol - Advanced Mastery Review

  • Protocol Deviations and Violations

  • Inclusion and Exclusion Criteria in Clinical Research

  • IND Application

  • IND and NDA Process

• Documents & Informed Consent

  • Source Documents and Informed Consent Forms

  • Informed Consent (ICH GCP Section 4.8)

  • Trial Management, Data Handling, and Record Keeping

  • Compliance with E-Signatures CFR 21 Part 11

  • Essential Regulatory Documents Guidance and Binder Tabs (Part 1)

  • Essential Regulatory Documents Guidance and Binder Tabs (Part 2)

  • Guidelines for Designing and Completing Case Report Forms

  • Do’s and Don’ts of a Case Report Form Design

  • Investigators Brochures

  • Trial Master File and DIA Model

  • Trial Master File Reference Guide

  • Financial Disclosure- Duties and Strategies for Clinical Studies

  • Financial Disclosures and Conflicts of Interest in Clinical Research

Adverse Events

• Advanced Review of Adverse Events

• Reporting of Adverse Events

• Safety Reporting Requirements for Sponsor Investigators of An IND

Site Visits And Audits

• Overview of Types of Monitoring Visits

• Site and Investigator Selection

• Site Selection/Qualification Visit (Pre-Study Visit)

• Site Close Out Visit

• Audits vs. Inspections

• FDA Warning Letter

• Site FDA Audit Inspection Checklist

• How to Survive Through an FDA Inspection

• Do and Don’ts during an FDA Inspection

• Patient Safety, Recruitment, And Compliance

Introduction & History of ICH GCP

• Compliance Requirements in Clinical Trials

• Subject Recruitment and Retention (Part 1)

• Subject Recruitment and Retention (Part 2)

• Safety of Human Subjects in Clinical Research

• Ethics of Research Involving Pregnant Women and Fetuses

• Ethics of Research Involving Mentally Incapacitated

• Ethics of Research Involving Children

• Scientific Misconduct in Research and How to Prevent It

• Increasing Subject Compliance in Clinical Trials

• Misconduct in Research – Detecting Falsification

Self-Assessments

• Self-Assessment MiniQuiz 1

• Self-Assessment MiniQuiz 2

• Self-Assessment Quiz A

• Self-Assessment Quiz B

• Final Quiz

The Drug Development Process for PIs:

In the first module of training, PI is introduced with the clinical research trials, phases, pre- clinical research, drug developing method and dealing with common difficulties. PI must be aware of the purpose of clinical trials which are conducted to develop a drug to ultimately leading to the capable the drug used for prevention, diagnosis and treatment of disease.

The main objectives of the clinical trials include:

• Treatment is the common fascination for the subjects to participate in the trials as

  it provides them with medicine for treatment and diagnosis.

• Observational studies enable the investigator to find the relationship between the

  habits of socioeconomic group and the progress pattern of disease.

• Prevention type of studies include subjects who want to prevent the disease rather

  than treatment. Such kind of studies require the personnel having family history of

  the disease.

• Diagnostic type of trials is used to treat the disease efficiently.

• Basic science by its nature allows to concentrate upon the phenomenon, closed

  observation, experimentation of hypothesis, extracting conclusion to develop a new approach.

  Pre-clinical trials as the name indicates are performed before the clinical trials and commonly known as Phase 0 trials involve First-in-man trials to know about the safety of the drugs and allows the determination of amount of safe dose of drug. This kind of trial is used to test the new medical devices, diagnostic tools, gene therapy and drugs.

There are mainly 4 phases of clinical research trials.

Phase 01. Determination of pharmacology and tolerability
Phase 02. Evaluation of safety and efficacy
Phase 03. Evaluation of safety and risk ratio as well as effectiveness. Successful completion of phase 3 trials leads to submission of application for the FDA approval.
Phase 04. Monitoring long term effects and effectiveness. Successful phase 4 trials are considered as FDA approved drug.

The Role of Principal Investigator:

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A person responsible for the conduct, preparation, research grants, agreements, training or public service project, contract or other sponsored projects in compliance with applicable laws and regulations and policy governing the conduct of sponsored research.
FDA recommends a form duly filled and signed by the investigator which serves as a statement from the side of investigator is known as FDA form 1572

Major Roles of PI:

The major roles of the PI are The Position roles (managing the integrity of design and collaborative results, reporting to the individuals like dean , department head and divisional chief),coordination with the administration, scientific proposal preparation, arranging and managing budgets, preparation of protocol according to the regulations and assuring the approval of any changes before implementation, acceptance of award in the light of rules and regulations, Conducting research (supervision to implement the rules, supervision of the team to ensure ethical conduct, reporting any misconduct), applying appropriate cost rate to the facilities and administrative, allocation of space to conduct the research, arranging equipment for study etc.

ICH has provided adequate GCP for Investigator to work effectively. These guidelines provide information about following aspects:

• Qualification and dealing with the agreements.

• Adequate resources in terms of staff and budget.

• Protection of the rights and safety of trials subjects either human or animals.

• Procedure of communication with regulatory bodies like IRB/IEC.

• Following and implementation of the rules and protocols set by regulatory bodies,

• Allowing the supervision of the investigational product to a qualified and responsible

  person.

• Responsibilities regarding design of studies (randomization and blinding).

• Arranging the informed consent of individuals.

• Keeping records and reporting to the regulatory bodies.

• Safety reporting

• Termination or suspension of the trials before time.

• Submission of final reports.

Informed Consent:

A document signed by every volunteer participating in the trial by informing him /her regarding all the matters of trials like, either he /she is voluntarily participating in the trials, informed about the risks, clarifying the role in trials and procedure of study. Federally, it is compulsory to get signed informed consent before participation in the clinical trials.

This link provides all the information regarding inform consent form and ICF review sample.

To effectively complete the consent process, interviewer should provide sufficient time to the participant to think that either he should participate or not. This process also allows the participants to review the procedure and frequently ask any query related to the trials. This process must be transparent and free of influences.

For developing a consent form standard UCI, IRB consent template must be followed. It must include the following key points.

• General information regarding purpose, design, and statement of study.

• Objective of the study must be clear including an appropriate definition that why

  FDA testing is necessary.

• Complete description of the process either in tabular or descriptive form comprising

  of complete description of stages involved in process, inclusion/ exclusion criteria,

  type of questions in case of questionnaire.

• Risks associated with the study must be properly defined in tabular or descriptive

  form. If risks are not clear, then a statement must be added that any unforeseeable

  risk can occur.

• To clarify the participant can withdraw or Investigator can terminate any participant

  at any time. It is investigator’s responsibility to clarify the procedure of the

  withdrawal from the study when participant wants.

• Confidentiality must be maintained regarding the subject’s information, procedure,

  and research data and about the record keeper.

• Investigator will provide new information to the subject by standard text.

• Or the benefit of the participant who wants to withdraw from the studies, extra

  courses or benefits must be explained in an appropriate way.

• Research member’s financial interest in the study must be mentioned as well as the

  specimen collection should be informed.

• It must be clearly written that the subject has the right to either participate or not in

  the study.

• Signature line for participant and authorizing member must be included. Witness

  line shall also be included in some kind of studies where necessary.

The Clinical Research Protocol:

Protocol is the document describing the procedure of conducting clinical trials ensuring the safety of subjects or volunteers and integrity of collected data. This document must comprise of following headings and details regarding trials:

• Title page

• Background information

• Objective /purpose

• Study design

• Inclusion and exclusion of subjects

• Treatment of subjects

• Evaluation and assessment of safety and efficacy

• Adverse events

• Suspension of study

• Statistical data

• QC and QA

• Ethics

• Data handling and record keeping

• Publication policy

• Project timetable

• References

Appendices

The NIH also provides templates and resources to develop the protocols and designs to conduct the trials.
When the activities without any significant reason diverge from the IRB approved protocol the is known as protocol deviation.

Adherence to the trial related requirements, following GCP requirements, and fulfilling regulatory requirements is known as Protocol compliance.

Understanding Adverse events:

Adverse event is defined as an unintended and unwanted sign, symptom or disease partially associated with the use of drug without any judgement about causality and relationship to the drug.
If a sponsor or investigator based on outcomes (death, life threatening adverse reaction, In-patient hospitalization or disruption life functions) considers the adverse event or reaction serious.

All adverse events should be documented in the patient’s medical record. To collect AE’s patients should not be asked anticipated questions either they should be asked the open- ended questions, during examination and evaluation. A progress note must contain good clinical practice and good clinical practice research. Report must contain date of AE initiation, attribution of AE, date of resolved AE, documentation of worsen or untreated AE.

Recording of AE onto a case report form (CRF) includes details:

• Date of initiation of AE

• Treatment of AE

• Garde of severity

• Attribute of AE

• AE resolved date.

• For worsen condition or treatment changing progress or any relationship should be

  documented on the other CRF form

Reporting to regulatory bodies involves routine and expedited.

IND Safety reports (ISR) comprised of all types of adverse events, In vitro testing details, findings of other studies and all other suspected adverse events.

Format for submission of an ISR include Narrative ( all kind of data either published or unpublished analysis data),
FDA form 

Council of International Organization Medical Sciences Form  

Electronic FDA Form 

Source Documentation

A pharmaceutical company or sponsor provide or sends the new drug for approval to the FDA including all the data of clinical trials. The FDA then asks for the provision of the source data from where it was captured. This documented data is called source document.

Essential documents in clinical trials

Investigator’s Brochure, study protocol, Informed consent or subject information, reports of research trials and case report form.

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1. Firstly, Investigator brochure (IB) contains information about the investigational drug before and after the performing he clinical studies in a brief and concise manner. This document is comprised of keywords and abbreviations, contents list, brief description of the investigational drug, general approach towards study and brief description as introduction, characteristics of the medicinal product, nonclinical and clinical studies and at the end conclusion and references.

2. Secondly, Clinical Study Protocol is a documentation of goals, objective, and design of clinical study. This document is designed after the instructions of all parties participating in clinical trials and this document should contain all the information regarding clinical trials and then sent to the authorities for review.

3. Thirdly, when any amendment is made in the study protocol, protocol amendment document is used. Before implementation it must be again approved by the authorities.

4. Fourth, Informed consent is the document to ensure that the volunteers are perfectly aware of the objective of trials, Investigational product. This document depends upon the willingness of the volunteers and they have right to leave the trials.

5. Fifth, Study progress reports are prepared by the medical monitor either on daily basis or final report is prepared to show the committees.

6. Sixth, Case record form is the document to record the data of individuals involved in the study. It could either be an electronic document.

7. Responsibilities of an investigator according to GCP guidelines include:

• Supervision of the conduct of clinical investigation.

• Delegation of the duties to the qualified personnel.

• Training of the participating staff

• Arranging an individual for the supervision of each site.

Protection of rights, safety and welfare of study objects.

Communication with IRB requires high level of professionalism for which PI assigns this duty to Regulatory document specialist (RSD) and documentation of this communication is maintained.
SOP’s for communication are provided in this link.

Deviation’s fraud and noncompliance:

When IRB or any committee sets regulations, rules, policies, and laws and rely upon the organization or any person to imply them, then any failure in implementation of these rules is commonly described as noncompliance. To overcome this issue, NLM has created a website and provided the time frame to government and private trials conducting bodies to register and provide the results within the given time frame.

A term fraud is commonly used in clinical trials which means contravention of faith and dealing intentionally, to harm any individual by manipulating the research data and results. It also includes deviating from the set protocols, policies and manipulating data and research results. The question arises that how and why fraud occurs in clinical trials. There are some points summarized to explain it.

• To gain fame by participating in internationally renowned trials.

• Manipulating data of repeated testing due to lethargy of research staff or

  investigator.

• Rule’s policies and incentives attached to the trials are the environmental factors.

• Idiosyncrasies, ego, competition among colleague investigators, for increasing the

  tenure and promotion.

When an investigator either intentionally or unintentionally fails to comply with the policies and regulatory requirements, FDA has authority to disqualify him either permanently or temporarily. This disqualified investigator is not allowed to conduct any kind of investigations regulated by FDA.

The main steps or headings of disqualification of an investigator by FDA are described here.

• The Disqualification processes.
o Issuance of notification for disqualifying an investigator and providing an opportunity to explain.
o Consent agreement
o Summon of hearing as an opportunity after disqualification. o After hearing taking crucial decisions
o Actions upon disqualification:

• Criminal prosecutions

• Revealing the information regarding decision of disqualification

• Reinstatement of disqualified investigator 

• The link for the detail study: FDA proceeding

How to Become a Clinical Research Assistant: A Complete Guide to Becoming A CTA with No Experience on Resume

How To Become A Clinical Research Assistant

A Complete Guide To Becoming A Clinical Trial Assistant With No Experience On Resume

Clinical Research Assistant

The work of a clinical trial/research assistant (CTA) in clinical research can never be overstated. It is an important career that requires a lot of interest and dedication in order to be successful. If you have developed interest in becoming a CTA, there are certain questions that you must ask yourself. Are you really cut out for this career path? Are you eager to take up more responsibilities in a work place? Can you monitor the trial subject and ensure that the trial is conducted in a safe and ethical manner? If your answers to this questions are yes, then you might just be cut out for the job of a clinical trial assistant. 

CCRPS offers the only accredited 5-day, on-demand advanced clinical research assistant certification (ACRAC) course available to help your learn and apply knowledge and increase your chances of 1) getting a job 2) being efficient and successful in your career.

Responsibilities of a Clinical Research Assistant

A clinical trial assistant have a lot of responsibilities and roles to fulfill within a clinical research institute to ensure the success of a project. Some of these responsibilities include:

• Maintaining the standard operating procedures (SOP). 

• Provide regular report updates of the progress of clinical studies to the appropriate personnel. 

• Planning and conducting of pre-study site evaluation. 

• Conduct clinical site feasibility and are as well involved in study visibility. 

• Assess the study subjects to ensure that the appropriate clinical protocols are observed and the trial is in sync with laid down regulations. 

Research Assistant Job Description

Participate in the design, administration and monitoring of clinical trials. Analyze and evaluate clinical data gathered during research. Ensure compliance with protocol and overall clinical objectives.

May require a BS, RN, or BSN degree or equivalent and 0-3 years of experience in the field or in a related area. Knowledge of FDA regulatory requirements is required. Has knowledge of commonly-used concepts, practices and procedures within a particular field. Rely on instructions and pre-established guidelines to perform the functions of the job. Work under immediate supervision. Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager.

Minimum Education Requirements For Clinical Trial Assistant

Requirements:

• Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis

  High school diploma or equivalent; college degree preferred

The educational requirement for a clinical research assistant is at the very least a high school diploma or associate degree in a health science. That's the least requirement, although more employers now prefer a B.Sc degree. Even if you don’t have a health science degree. if you took sciences related courses like nursing, life sciences, medical science, biotechnology, you should absolutely let the companies you are applying to know.

Another avenue you can become a clinical trial assistant is through certification. This is possible and is most common for people without formal education in the fields mentioned. Certification can be very demanding as it requires a lot of administrative knowledge in the area of clinical research. Many CTAs move on to become CRCs, CRAs, and administrators.

Skills You Need To Show On Your Research Assistant Resume

To be successful as a clinical research assistant, there are certain skill sets that are required. 

• A knowledge of the challenges and restrictions involved in the implementation and retention of databases. 

• A complete understanding of the responsibilities and liabilities involved in the use of humans for trial tests. 

• An ability to make excellent clinical development plan. 

• Must be able to ensure that data gotten from clinical trials are accurate and reliable and the legal rights and privacy of the subjects are protected. 

Having these above listed skills and being efficient in them make the job of a clinical trial assistant easier and more interesting. 
Responsibilities:

• Conduct literature reviews

• Collect and analyze data

• Prepare materials for submission to granting agencies and foundations

• Prepare interview questions

• Recruit and/or interview subjects

• Maintain accurate records of interviews, safeguarding the confidentiality of subjects, as necessary

• Summarize interviews

• Provide ready access to all experimental data for the faculty researcher and/or supervisor

• Request or acquire equipment or supplies necessary for the project

• Manage and respond to project related email

• Prepare, maintain and update website materials

• Supervise undergraduate students working on the research project (maintaining records on assignment completion, acting as liaison/mediator between the undergraduate students and the faculty researcher)

• Attend project meetings

• Attend area seminars and other meetings as necessary

• Summarize project results

• Prepare progress reports

• Prepare other articles, reports and presentations

• Monitor the project budget

• Travel to field sites to collect and record data and/or samples as appropriate to the specific objectives of the study

• As appropriate to the specified position, code and verify data in accordance with specified research protocol and coding procedures and enter data into a computer database and/or spreadsheet application for subsequent analysis

• Develop or assist in the development of interview schedules; contact potential subjects to introduce and explain study objectives and protocol and to arrange interviews, either in person or by telephone

• Identify and compile lists of potential research subjects in accordance with study objectives and parameters, as appropriate to the individual position

• Conduct and record face-to-face and/or telephone interviews with subjects, in accordance with predetermined interview protocol, data collection procedures and documentation standards

• Review and edit data to ensure completeness and accuracy of information; follow up with subjects to resolve problems or clarify data collected

• May set up, calibrate and maintain laboratory and/or field research equipment, as specified by the requirements of the study

• May lead or guide the work of student employees

• Perform miscellaneous job-related duties as assigned

• Prepare findings for publication and assist in laboratory analysis, quality control, or data management

• Write and contribute to publications

• Develop research protocols

• Track progress over time

• Assist with preparation of all educational and training workshops and evaluation strategies

• Engage clinical and community partners in research

• Market training and technical assistance resources to clinical partners and academic investigators

• Develop assessment and evaluation tools

• Compile data for progress reports

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Where To Reach Out For Trial Assistant Experiences And Internships

Landing that first trial assistant experience or internship can be a stepping stone to a rewarding career in clinical research. In this blog, we'll explore various avenues to find these valuable opportunities and launch your journey in this dynamic field.

Education and Certification:

While not always mandatory, a degree in a life sciences field like biology, health sciences, or nursing can be beneficial. However, even without a degree, you can break into the field. Consider pursuing a certification program offered by organizations like the Association of Clinical Research Professionals (ACRP) to demonstrate your knowledge and commitment.

Finding Trial Assistant Opportunities:

• Industry-Specific Platforms: Leverage job boards frequented by the clinical research community. Look for platforms like Society for Clinical Research Associates (SOCRA) or ACRP job boards. These boards often list internship and entry-level positions specifically for Clinical Trial Assistants (CTAs).

• General Job Boards: Don't neglect popular job boards like Indeed or LinkedIn. Utilize relevant keywords like "clinical trial assistant internship" or "research assistant" to filter your search and uncover a wider range of opportunities.

University Resources:

• Career Services Departments: Many universities have dedicated career centers that assist students in finding internships. Connect with your career advisor to discuss your interest in clinical research and explore internship opportunities within the university or with partnering institutions.

• Research Departments: Universities often conduct their own clinical trials. Reach out to professors or research departments to inquire about potential research assistant positions. This can provide valuable hands-on experience.

Government Websites:

• Regulatory Agencies: The US Food and Drug Administration (FDA) offers student volunteer programs ([resources for getting experience in clinical research]).

Networking:

• Professional Associations: Join associations like ACRP or SOCRA. Attend industry conferences or webinars to connect with professionals, learn about the field, and discover potential internship or job openings.

• LinkedIn: Build your professional profile on LinkedIn and connect with individuals working in clinical research. Reach out to them politely and express your interest in gaining experience. Show genuine curiosity and highlight your transferable skills.

Local Directories:

• CTAs can leverage online directories to target their search. After obtaining your certification, reach out to request experiences or internships at:

  • Clinical research organizations (CROs)

  • Pharmaceutical companies

  • Biotechnology companies

These directories can be found through professional association websites or a simple online search using terms like "USA clinical trial directory" or "USA CRO directory". Here are some examples:

• ClinicalTrials.gov (a comprehensive listing of clinical trials registered in the US)

• CRO Directory (searchable directory of contract research organizations)

• BioPharmCatalyst (industry resource with listings of clinical trials and CROs)

Volunteering:

• Hospitals and Research Institutions: Volunteer at hospitals or research institutions involved in clinical trials. This can provide valuable firsthand experience and build connections with professionals in the field.

Additional Tips:

• Tailor Your Resume and Cover Letter: Highlight relevant coursework, volunteer experiences, and any transferable skills that demonstrate your aptitude for the role. Research the specific company or institution you're applying to and tailor your application to their needs.

• Be Proactive: Don't wait for opportunities to come to you. Research companies conducting trials in your area and directly contact their clinical research departments. Express your enthusiasm and willingness to learn.

By exploring these avenues and demonstrating your enthusiasm, you'll increase your chances of landing a trial assistant experience or internship and taking that crucial first step towards a fulfilling career in clinical research.

Clinical Trial Assistant Training

Unlike the hundreds of CTAs who apply to a position, you can give your resume and interview a huge advantage by having certification. CCRPS' offers complete clinical trial assistant training and certification by the ACCRE through our clinical trial assistant training course. Certification as a CTA can help you show competency to work and apply for roles; many students use the course as a way to update their resume and land the interview at the site they desire. If you plan to continue a career in clinical research, ask our 24/7 chat and phone advisors for partial scholarships. We also offer up to 4 month payment plans ($100 per month).

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Advanced Clinical Trial Assistant Training: CTA Syllabus CCRPS

DEMO COURSE

Introduction 

• Accreditation Council For Clinical Research & Education for CCRPS

  Fundamentals Of Clinical Research

  • An Introduction to Clinical Research

  • An Overview of ICH GCP

  • Code of Federal Regulations

  • CFR 21 Part 11

  Clinical Trial Roles And Responsibilities

  • Sponsor/CRO Responsibilities

  • 13 Principles, IRB, & Investigator Roles

  Informed Consent & Patient Safety

  • Informed Consent FREE PREVIEW

  • Safety of Human Subjects in Clinical Research  FREE PREVIEW

  Adverse Event Reporting & Responsibilities 

  • Reporting Responsibilities of the Investigators

  • Adverse Events

Ethical Research In Vulnerable Populations

• Ethics of Research Involving Children

• Ethics of Research Involving Mentally Incapacitated FREE PREVIEW

• Ethics of Research Involving Pregnant Women and Fetuses

• Ethics of Research Involving Prisoners

Trial Management, Data Handling, And Record Retention

• Trial Management – Data Handling and Record Retention

• a) Common Terminology Used In Clinical Research

• b) Commonly Used Abbreviations and Terms in Clinical Research

Clinical Trials - Advanced Review

• Advanced Designs of Clinical Trials

• Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

  FREE PREVIEW

Subject Recruitment, Retention, And Compliance

• Patient Recruitment in Clinical Trials 

• Patient Engagement and Retention in Clinical Trials 

• Patient Adherence and Compliance in Clinical Trials 

Misconduct And Fraud 

• Scientific Misconduct and Fraud 

• Detecting Falsification

Clinical Trial Assistant Certification Exam

• ICH GCP Clinical Trials Assistant Exam (30 Questions)

What To Know For Clinical Trial Assistant Interview Questions

The work of a clinical research assistant is one of extreme importance to the clinical research institute, and employers will to testing to see if you understand what position entails.

Clinical research assistants is to test new medications, therapies and types of treatment and new medical devices to be sure of the safety of their use and the efficacy or efficiency of their work. These clinical trials are very much regulated and seriously monitored to ensure that they comply with the laid down regulations. The need to keep various records, in order to meet up with compliance requirements can be a burden. That is where clinical research assistants come in.

Clinical research assistant are responsible for performing the different safety and quality checks within their unit. Some of these checks are routinely carried out daily, weekly or monthly.  The daily checks are usually the first thing they carry out on resuming to work everyday. This is to ensure the safety of all the staffs and volunteers within the clinical research institute and as well improve the quality of the data collected and the results.  

The job of a clinical research assistant is to help in finding subjects that can be used for clinical trials, they are responsible for collecting and analyzing the data gotten from clinical tests and trials and they also evaluate the result. They are the ones that keep all the record of activities in the clinical research institute for the purpose of references. They practically ensure that the clinical trial activities are in line with laid down regulations. The amount of data to be collected, evaluated and stored form the trials make this job an important one. That means it is a job in high demand.

Their importance means that there are a variety of places where they can work. Clinical research assistants can work at clinical research institutes, medical centers, pharmaceutical companies, biotech companies and a whole host of other medically and clinically inclined organizations. 

The standard equipment like freezers and fridges are checked at least twice daily. This is important because they are used for storing specific research samples and other medications that needs to be kept in controlled temperature and a slight deviation from that can affect the validity of the result and the research. The emergency equipment are also checked regularly on a daily basis.

Part of a clinical research assistant's job is to assist all members of the team and deal with different queries from members of the public. It is also their duty to control all medical stock used in their unit, prepare materials for screening visits, prepare consent forms, questionnaires and information sheets and keeping study files while archiving the files for completed studies.

In the midst of these many duties, it is very important that the clinical research assistant is very capable of multitasking. A good communication skill (both written and verbal) is very important to do this work successfully. One thing that is a must for anyone aspiring to take up this job is to have a keen eye for details. It is also important to be able to ask the right question and develop your knowledge base as much as possible. If you can demonstrate that you have these skills in your interview, you should be all set to go.

Clinical Research Assistant Salary

Per Payscale

The salary of a clinical research assistant can vary depending on different factors like location, institution or employer etc. However, the average yearly salary is $41,000 at an hourly average of $17. It can rise as high as $55,000 or as low as $32,000.

If you'll like to apply for the post of a clinical research assistant, it makes it easier for you if you have B.Sc in life science or social science related courses. If you don't, go enroll for a bachelor's degree and get experiences by volunteering in clinical trials

The purpose of clinical research is to test new medications, therapies, and new medical devices to be sure of the safety of their use and their efficiency. These clinical trials are very much regulated and seriously monitored to ensure that they comply with the laid down regulations. The need to keep various records, in order to meet up with compliance requirements can be a burden.

That is where clinical research assistants come in….

CTA Salary Prediction Provided by Payscale

CCRPS offers the only clinical research assistant certification (ACRAC) course available

The job of a clinical research assistant is to help in finding subjects that can be used for clinical trials, collecting and analyzing the data from clinical tests, and they also evaluate the result.

They are the ones who keep all the record of activities in the clinical research institute for future references. They practically ensure that the clinical trial activities are in line with laid down regulations. The amount of data to be collected, evaluated and stored form the trials make this job an important one. That means it is a job in high demand.

Their importance means that there are a variety of places where they can work. Clinical research assistants can work at clinical research institutes, medical centers, pharmaceutical companies, biotech companies and a whole host of other medically and clinically inclined organizations.

The educational requirements required to work as a clinical research assistant includes a bachelor’s degree, master’s degree or a doctorate degree in life sciences or other medical related sciences.

These are just basic educational requirements, if you are interested in getting into clinical research, you need more than just degrees in life science. Not because they are not important but because they do not offer you the core knowledge and experience needed to be successful in this career. Based on your chosen discipline in clinical research, you can choose to offer courses related to your discipline and you will be taught by seasoned and experience lecturers in the industry keen to pass on their knowledge and experience. You can also register to be a member of clinical research based associations at CCRPS and find more expert information on the clinical research field. All you need to have a rapid career is right here.

CCRPS offers the only accredited 5-day, on-demand clinical research assistant certification (ACRAC) course available to help your learn and apply knowledge and increase your chances of 1) getting a job 2) being efficient and successful in your career.

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Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

What Is Pharmacovigilance? - Definition, Jobs, Salary, And Pharmacovigilance Certification

Pharmacovigilance

A Guide All About Pharmacovigilance

To increase your chances of getting hired or promoted, scroll below or enroll in our CCRPS Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM Course which covers drug safety and pharmacovigilance training

What is pharmacovigilance?

Pharmacovigilance Is The Study Of Two Primary Outcomes In The Pharmaceutical Industry:

Safety And Efficacy.

Essentially, it asks does a drug work and is it safe?

Pharmacovigilance is the process of monitoring the effects of drugs, both new and existing ones. This includes collecting data, analyzing it, and taking steps to prevent any negative effects. Pharmacovigilance must happen throughout the entire life cycle of a drug, from when it is first being developed to long after it has been released on the market.

What is the Aim Of Pharmacovigilance?

Pharmacovigilance is required through the entire life cycle of a drug – starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market.

Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies.

It can be broken down into three main sub-specialisms:

1. Surveillance: Surveillance is geared towards risk management and signal detection. Roles in this specialism focus analysis of drug safety information gathered from other professionals. Surveillance is responsible for creating development safety update reports (DSURs) for drugs in clinical research and periodic benefit-risk evaluation reports (PBRER) for drugs that are on the market.

2. Operations: Operations focus on collecting and recording information during preclinical development, early clinical trials, and gathering real-world evidence (RWE) of adverse events reported by medical professionals and patients. Operations may also create standard operating procedures (SOPs), individual case study reports, and regulatory reports.

3. Systems: Systems is concerned with the development of robust systems to store and manage data relating to pharmacovigilance. It involves keeping abreast of changing regulations and guidance in the pharmacovigilance industry and ensuring compliance at all levels of an organization.

The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that an organization's pharmacovigilance system meets all applicable requirements.

What is Pharmacovigilance Training?

If you’re looking to boost your career prospects in the pharmaceutical industry, drug safety training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, certification is crucial.

If you run a company and want to provide your staff with drug safety training to increase their knowledge and provide a safer working environment, our course is for you too.

We even help train Senior PVs from Fortune 500 companies to improve their efficiency and compliance.

No experience? No worries!

Our triple-accredited Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM is designed to teach you all you need to know in just 1 week!

Recognized Drug Safety Training I 180 Hours I On-Demand I Accredited I 25+ Modules I Training Compliance I Instant Enrolment I 1+Wk Certification I

What do Pharmacovigilance Officers do?

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The exact nature of each role varies, but in essence, Pharmacovigilance Officers (PVs) collect adverse event data on drugs (Phase 4) to analyse and create usage warnings for the drug.

Some roles insist on physicians, nurses, or those with a Master of Science degree. A Master’s in pharmacovigilance is your best route into the industry – but that takes up to 2 years and is very expensive.

Your quicker route into the industry is with a drug safety accreditation.

Please note: A minimum of an associate degree is required to take any training course, including ours.

How To Get Into Pharmacovigilance

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The CCRPS pharmacovigilance certification to provide advanced training for entry level pharmacovigilance to ensure you are fully prepared for a career in drug safety monitoring. We are a non-profit organization dedicated to providing advanced pharmacovigilance training to students at all stages of their careers.

The courses provide you with theory and practical-based learning in pharmacovigilance and give you vital industry experience.

Our pharmacovigilance training courses meet
WHO-ISoP and FDA guidelines and are accredited by the ACCRE and other recognized accreditation boards.

You’ll learn the basics of pharmacovigilance, why it’s necessary, its history, and how to find career opportunities within the industry.

You’ll look at different methodologies, pharmacovigilance regulation, pharmacovigilance audit and risk management, and vaccine pharmacovigilance.

You’ll also discover where to find further information to enhance your pharmacovigilance knowledge and study individual case reports to get to grips with the finer details of the subject.

At the end of the course, you will receive your certification. Then you’re ready to set out on your pharmacovigilance career.

After achieving your certification, you’ll open up a world of opportunities in pharmacovigilance and be qualified for entry-level roles including, but not limited to the following Drug Safety Jobs:

Pharmacovigilance Jobs

Pharmacovigilance Jobs Entry Level

Remote Pharmacovigilance Jobs

18,000 Pharmacovigilance Jobs (always include a SPECIFIC cover letter for all jobs and follow up at least twice by email if you do not hear back to show interest to every single job).

• Drug safety or Pharmacovigilance scientist (specialist or associate)

• Drug safety or PV manager

• Safety or PV reviewer

• Pharmacovigilance Quality Compliance

• Clinical Quality specialist

• Medical Safety scientist/specialist/reviewer

• Local safety officer

• Clinical trial project safety associate (reviewer or specialist)

• MedDRA coder

• Pharmacovigilance safety and analytics reporting analyst/specialist/associate

• Pharmacovigilance Auditor or PV Inspection readiness officer

  • Safety or Pharmacovigilance Physician (medical director, MD/MBBS, IMG)

  • Safety Compliance Writer

  • Good PV Practices manager

  • GCP specialist

  • Pharmacovigilance vendor

  • Case processing specialist

  • Clinical trial case processing safety specialist

  • Post-marketing case processing safety specialist

  • Epidemiology safety associate (MPH) • Risk management manager
  • Signal management specialist
  • Periodic reporting specialist

  • Regulatory affairs safety specialist

  You’ll also be qualified to act as an onsite safety representative for the duration of a given contract.

Pharmacovigilance Salary

The pandemic has demonstrated just how vital the pharmaceutical industry is to the smooth running of the country and the economy. And with the average entry-level salary in pharmacovigilance in the region of $69,000, it provides a unique opportunity to do your duty and be well-rewarded.

Once you are experienced in
pharmacovigilance, you can expect to command a salary of around $114,000.

And after 3-10 years in the industry, you can expect to earn $136,000. Based on salary, the US is the best country for pharmacovigilance jobs although pharmacovigilance is paid well globally as well.

We have trained over 1,800 clinical research and pharmacovigilance professionals and cover global clinical safety and pharmacovigilance as well as argus safety data base certification in our online, on-demand course. Our drug safety training is provided online and can be completed in less than a week. This is a great alternative to a diploma course in pharmacovigilance as you can finish quickly and still get an advanced level of understanding under your belt.

You can speak with our enrollment advisors for assistance in pricing and scholarship. Completed certification helps demonstrate your interest and knowledge to employers.

A career in pharmacovigilance is rewarding both personally and financially.

But like all new career paths, it can be difficult to gain experience or demonstrate your commitment from the outside. Achieving an accredited PV certification shows potential employers that you are serious about a career in the industry. It proves that you have the required knowledge and understanding of pharmacovigilance to add value to their organization.

For further details, call and speak to one of our 24/7 enrollment representatives through the orange chat box.

Good pharmacovigilance practice - ICH GCP guidelines for pharmacovigilance

Pharmacovigilance certification

Online Pharmacovigilance Training Course

Pharmacovigilance Certification

by CCRPS pharmacovigilance training institute is a globally-accepted, accredited Online Pharmacovigilance Training Course

Fundamentals Of Global Pharmacovigilance

Introduction to Drug Safety and PV FREE PREVIEW

Key PV Terminology (Side Effect, Drug Safety, and Risk Terms) FREE PREVIEW

International Regulatory Requirements and Guidelines Overview FREE PREVIEW

Pharmacovigilance Quiz

Regional Regulatory Requirements (FDA, EMA, Japan, China) FREE PREVIEW

Postmarketing Surveillance (PMS) and Safety Management FREE PREVIEW

GVP - Pharmacovigilance Abbreviations Advanced Review of Adverse Event Reporting

Advanced Review Of Pharmacovigilance

Advanced Practice of Pharmacovigilance Pharmacovigilance Quiz

Additional Encompassing and Confusing Terms in Pharmacovigilance

MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)

Pharmacovigilance Quiz
Need for Pharmacovigilance
The History of Pharmacovigilance FREE PREVIEW Roles in Pharmacovigilance Pharmacovigilance Quiz
Key Stakeholders in Pharmacovigilance Pharmacovigilance Quiz

Post-marketing AE Processing and Reporting(ICSR, Case Processing, Narrative Writing, & International Aggregate Reporting)

Pharmacovigilance Quiz

Signal Detection (Detection, Validation, Prioritization, and Action)

Pharmacovigilance Quiz
Risk Assessment, Plan, and Management Pharmacovigilance Quiz

Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication, and Case Studies)

Post-authorization/Post-marketing Regulations in Pharmacovigilance

Argus Safety Database Certification

Argus Safety Database Certification Part 1 (Into and Video Demos)

Argus Safety Database Certification Part 2 Argus Safety Database Certification Part 3 Argus Safety Database Certification Part 4 Argus Safety Database Certification Part 5 Argus Safety Database Certification Part 6 Oracle Argus Safety User Guide

Resources

International Pharmacovigilance Initiatives and Guidelines - EMA

DIA Safety and Pharmacovigilance Competencies

Pharmacovigilance Career Resources

WHO-ISoP Pharmacovigilance Resources

E2E-Pharmacovigilance Planning

GVP XVI Addendum: Educational Materials

GVP Module I-IV PV Systems, PSMF, Inspections & Audits

GVP I: Pharmacovigilance Systems

GVP VIII: Post-authorisation Safety Studies

GVP III: Pharmacovigilance Inspections

GVP IX Addendum: Methodological aspects

GVP V: Risk management systems

GVP IX: Signal management-

GVP VIII Addendum: Requirements- recommendations_en-1

GVP XV: Safety Communication

GVP XVI: Risk-minimization measures

GVP II: Pharmacovigilance System Master File

GVP VI: Duplicate Management

GVI VI: Pharmacovigilance Audits

GVP X: Additional Monitoring

GVP VII: Periodic Safety Update Report

GVP VI: Collection, management, and submission of reports

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PV Resources

Getting Started in Pharmacovigilance Part 1

Recruiters Career Pathways in PV

Reading Resources

Cobert’s Manual of Pharmacovigilance and Drug Safety

Mann’s Pharmacovigilance

Drug Safety Data

Pharmacovigilance Definition

Investigational product (IP): Any drug, device, therapy, or intervention after Phase I trial

Event: Any undesirable outcome (i.e. undesired laboratory finding, symptom, or disease)

Adverse event/experience (AE): Any related OR unrelated event occurring during use of IP

Adverse drug reaction/effect (ADR/ADE): AE that is related to product

Serious Adverse Event (SAE): AE that causes death, disability, incapacity, is life- threatening, requires/prolongs hospitalization, or leads to birth defect

Unexpected Adverse Event (UAE): AE that is not previously listed on product information

Unexpected Adverse Reaction: ADR that is not previously listed on product information

Suspected Unexpected Serious Adverse Reaction (SUSAR): Serious + Unexpected + ADR

Causality assessment: Review of drug (i.e. pharmacology, pathophysiology, time overlap of event and IP administration, dechallenge and rechallenge, confounding patient-specific disease manifestations or other medications, and other explanations) to determine if certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable.

Dechallenge vs. Rechallenge: Causality assessed by measuring AE outcomes when withdrawing vs. re-administering IP

Causal relationship: Determined to be certain, probable/likely, or possible (AE + Causal -> ADR)

Seriousness: based on outcome + guide to reporting obligations (i.e. death SAE -> report in 3 days) mnemonic: seriOOusness = OutcOme

• Severity: based on intensity (mild, moderate, severe) regardless of medical outcome (i.e. severe headache -> not serious) mnemonic: severiTTy = InTensiTy

• Temporal relationship: Positive if AE timing within use or half-life of drug (positive, suggestive, compatible, weak, negative)

• Signal: Event information after drug approved providing new adverse or beneficial knowledge about IP that justifies further studying (PMS = signal detection, validation, confirmation, analysis, & assessment and recommendation for action)

• Identified risk: Event noticed in signal evaluation known to be related/listed on product information

• Potential risk: Event noticed in signal evaluation scientifically related to product but not listed on product information

• Important risk/Safety concern: Identified or potential risk that can impact risk-benefit ratio

• Risk-benefit ratio: Ratio of IP’s positive therapeutic effect to risks of safety/efficacy

• Summary of product characteristics (SmPC/SPC): guide for doctors to use IP

Good Pharmacovigilance Practice - ICH GCP guidelines for pharmacovigilance

• E2A: Clinical safety data management: Definitions and standards for expedited reporting

• What is e2b in pharmacovigilance? E2B: Electronic reporting of adverse events: Implements electronic reporting R3 E-ICSR Implementation Guide I Link CIOMS I to E2B Guide

• E2C: Periodic benefit- risk evaluation report (PBRER): Format and content of safety updates for reporting at intervals to regulatory authorities

• E2D: Post-approval safety data management: Definitions and standards for expedited reporting: Guidance for gathering and reporting information

• E2E: Pharmacovigilance planning: Helps to make PMS plan, especially in early Phase IV

• E2F: Development Safety Update Report (DSUR): Standard for periodic reporting on drugs

• M1: Medical dictionary for Regulatory activities (MedDRA)

• M4: The Common Technical Document (CTD): Formatting of reports to regulatory bodies (M4 Organization, M4Quality, M4Safety, M4Efficacy)

• CIOMS I: The international reporting form (links with ICH E2B)

• CIOMS II: Periodic safety update reports manual

• CIOMS III: Core data sheets

• CIOMS IV: Benefit-risk assessments

• CIOMS V: Practical issues in Pharmacovigilance

• CIOMS VI: Clinical trial safety data

• CIOMS VII: Development safety update reports

• CIOMS VIII: Practical Aspects of Signal Detection in Pharmacovigilance

Global Pharmacovigilance laws and regulations - IAOCR Directory

Local Pharmacovigilance Regulatory Bodies

• Australia – Therapeutic Goods Administration (TGA)

  • New Zealand – MEDSAFE

  • North America

  • Canada – Health Canada ~2%

  • USA* – FDA: Food and Drug Administration ~33%

  • Central/South America

  • Argentina – ANMAT

  • Brazil – Agencia Nacional de Vigilancia Sanitaria (ANVISA)

  • Chile – Instituto de Salud Publico (ISP)

  • Columbia – Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)

  • Costa Rica – Ministerio de Salud

  • Cuba – CECMED

  • Dominican Republic – Dirección General de Drogas y Farmacias

  • Jamaica – Ministry of Health

  • Mexico – Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

  • Paraguay – Ministro de Salud Pública y Bienestar Social

  • Peru – Ministerio de Salud

  • Uruguay – Ministerio de Salud Publica

  • European Union* – EMA: European Medicines Agency ~17%

  • Armenia – Scientific Centre of Drug and Medical Technology Expertise

  • Austria – Agency for Health and Food Safety (AGES)

  • Belgium – Federal Agency for Medicines and Health Products

  • Bulgaria – Bulgarian Drug Agency

  • Croatia – Agency for Medicinal Products and Medical Devices of Croatia

  • Cyprus – Ministry of Health

  • Czech Republic – State Institute for Drug Control

  • Denmark – Danish Medicines Agency

  • Estonia – State Agency of Medicines

  • Finland – Finish Medicines Agency

  • France – Agence Nationale de Sécurité du Medicament et des Produits de Santé

  • Germany – Federal Institute for Drugs and Medical Devices

  • Georgia – Regulation Agency for Medical and Pharmaceutical Activities

  • Greece – National Organisation for Medicines

  • Hungary – National Institute of Pharmacy

  • Iceland – Icelandic Medicines Agency

  • Ireland – Irish Medicines Board

  • Italy – National Institute of Health

  • Lithuania – State Medicines Control Agency

  • Luxembourg – Ministry of Health

  • Malta – Maltese Medicines Authority

    Moldova – Medicines Agency

  • Netherlands – Medicines Evaluation Board

  • Norway – Norwegian Medicines Agency

  • Poland – The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

  • Portugal – National Authority of Medicines and Health Products

  • Romania – National Medicines Agency

  • Russia – Ministry of Health of the Russian Federation• Serbia – Medicines and Medical Devices Agency of Serbia

    • Slovakia – State Institute for Drug Control • Slovenia – Ministry of Health
    • Spain – Spanish Medicines Agency
    • Sweden – Medical Products Agency

    • Switzerland – Swiss Agency for Therapeutic Products

    • Ukraine – Ministry of Health

    • United Kingdom – Medicines and Healthcare Regulatory Agency (MHRA)

    • Bahrain – I-SEHA

    • Egypt – Ministry of Health

    • Iran – Ministry of Health

    • Israel – Ministry of Health

    • Jordan – Jordan Food and Drug Administration

    • Lebanon – Ministry of Public Health

    • Saudi Arabia – Saudi Food and Drug Authority

    • United Arab Emirates – Ministry of Health

    • Bangladesh – Directorate General of Drug Administration (DGDA)

    • Bhutan – Drug Regulatory Authority

    • China* – CFDA/NMPA: State Food and Drug Administration

    • India – Central Drug Standards Control Organization (CDSCO)

    • Indonesia – POM (Pengawas Obat dan Makanan)

    • JAPAN* – PMDA: Ministry of Health, Labour and Welfare ~12%

    • Korea (South) – Korean Food and Drug Administration (KFDA) ~1%

    • Laos – Food and Drug Department

    • Malaysia – Ministry of Health (MOH)

    • Nepal – Department of Drug Administration

    • Philippines – Department of Health (DOH)

    • Singapore – Health Sciences Authority (HSA)

    • Sri Lanka – Ministry of Health (MOH)

    • Taiwan (Republic of China) – Taiwan Food and Drug Administration (TFDA)

    • Thailand – Food and Drug Administration of Thailand

    • Vietnam – Drug Administration of Vietnam

    • Algeria – Ministry of Health and Population • Botswana – Ministry of Health (MOH)
    • Burkina Faso – Le Ministère de la Santé

    • Ghana – Food and Drugs Authority

    • Kenya – Pharmacy and Poisons Board

    • Morocco – Ministry of Health

    • Nigeria – National Agency for Food and Drug Administration and Control

    • Rwanda – Ministry of Health

    • Senegal – Ministère de la Santé et de l’Action Sociale

    • South Africa – Medicines Control Council (MCC)

    • Swaziland – Ministry of Health

    • Tanzania – Tanzania Food and Drug Authority (TFDA)

    • Uganda – National Drug Authority

Clinical Research Associate: A Full Guide on Becoming A CRA

Clinical Research Associate

A Complete Guide on How to Become a Clinical Research Associate

• Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

• As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

• This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

• For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

• Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

• Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

• Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

  CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

• his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

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Clinical Research Associate Certification Qualifications

Foreign Doctors Welcome: A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course.

Distinct Skillset: Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course.

Most Extensive Online Course: Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.

Superior Coursework: Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.

Diverse Career Opportunities: This high-demand science-based medical field offers diverse opportunities:

• Work in the Private Sector: Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification.

• Academic Opportunities: Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification.

Unmatched Flexibility and Knowledge: In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.

Why Take A CRA Certification Course

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•  The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

• This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

• If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

• Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

• These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

• They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

• Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

• During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

• The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

• Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

• In applying for the post of a clinical research associate, ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

• Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

• Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

• There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

• Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

• Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

• CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

• After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

• Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

• This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

• While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

• Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

• This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

  How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

• Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

  • The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

  • Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

  • One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

• Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

  • The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

  • In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

• Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

  • The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

  • Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

• One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

• Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

  • The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

    • In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

1. According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

2. The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

3. In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

4. Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

5. Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hinges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

1. In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

2. However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

3. For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

4. Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

• By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or as a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

• The simple answer is, yes, you can.

• You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

• Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

• Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

• With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

• So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

• As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

• Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

• To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

• Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

• *The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (American Nurses Credentialing Center), as well as Transcelerate Biopharma.

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

• Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

• Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

• The program places particular emphasis on ethical practices in research with vulnerable populations.

• Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

• They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

• Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

• A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

• Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

• A vital component of the training program involves empowering students to tackle challenging situations.

• For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

• In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

• These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.
  

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced Clinical Research Associate Certification (ACRAC)

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

References

1. https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

2. https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

3. https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

5. https://www.niaid.nih.gov/research/dmid-investigational-product

6. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

7. Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

8. https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

9. https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

10. https://iaocr.com/finding-first-clinical-research-job/

11. https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

13. St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

14. https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

15. https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

16. https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

17. https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

18. https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

19. https://acrpnet.org/certifications/cra-certification/

20. https://www.socra.org/certification/program-overview/

The Ultimate Guide to Clinical Research Monitoring

Clinical research monitoring plays a crucial role in the success of clinical trials, encompassing diverse activities to guarantee the safety and precision of collected data. The execution of clinical trials must adhere to regulatory standards, prioritize the protection of human study participants, and minimize potential health risks. Monitoring activities include auditing study sites, assessing data accuracy and completeness, protocol and amendment reviews, scrutiny of case report forms (CRFs), identification of deviations from standard operating procedures (SOPs) or protocols, management of corrective action plans (CAPs), safety report follow-ups, and tracking progress against enrollment goals.

For those interested in becoming involved in clinical trial management and oversight, the Advanced Clinical Research Project Manager Certification offers extensive training in these key areas.

Beyond data quality assessment, clinical research monitoring ensures compliance with regulatory standards such as GCP (Good Clinical Practices), ICH (International Conference on Harmonization), FDA regulations, and local laws. Those looking to deepen their understanding of these standards might find the ICH-GCP course particularly beneficial. Ongoing monitoring throughout a study, coupled with potential audits by sponsors or regulatory authorities, contributes to the accuracy, reliability, and applicability of clinical trial results for informed medical decisions.

Steps to Clinical Monitoring:

1. Craft a Robust Monitoring Strategy: Develop a thorough monitoring plan encompassing essential elements. This includes specifying the types of monitoring activities, setting the frequency of monitoring visits, outlining data collection methods, and establishing clear criteria for acceptable performance.

   • Aspiring Clinical Research Coordinators can enhance their strategy formulation skills through the Clinical Research Coordinator course.

2. Create Effective Documentation: Develop monitoring tools tailored to the protocol, including forms for recording information from site visits, source documents, data collection instruments, and case report forms (CRF). Additionally, establish a Monitoring Log or Tracking System to enhance accountability for study activities.

   • For detailed training on documentation practices, consider the Clinical Trials Assistant Training.

3. Conducting Monitors' Visits: Depending on the trial's complexity and regulatory mandates, execute pre-study qualification visits (PSQV), pre-initiation visits (PIV), initiation visits (IVs), periodic monitoring visits (PMV), and close-out visits (COV). Throughout each visit, uphold good clinical practice standards by thoroughly reviewing source documents and data collection instruments. Scrutinize patient enrollment logs for accuracy, noting any discrepancies in the comprehensive visit report.

   • The CRA course provides in-depth training for those looking to conduct these critical visits.

4. Reporting Findings: Create comprehensive yet succinct reports after each monitor's visit, offering clear recommendations for corrective actions as needed. Provide professional feedback to investigators, highlighting their performance. Identify and address any noncompliance with protocol requirements or regulations, suggesting training or educational sessions when necessary. Track all follow-up activities related to corrective actions taken in response to monitor's visit findings. Ensure the completion of essential documentation before closing out a specific study site.

   • Those interested in the oversight of safety reporting might explore the Pharmacovigilance Certification.

5. Ensuring Quality Assurance: Validate the accuracy of tracking systems employed by monitors during their visits. Assess the risks linked to identified deficiencies throughout the monitoring process. Conduct regular internal audits/assessments to guarantee compliance with established SOPs/guidelines pertaining to clinical research monitoring activities. Implement preventive measures based on audit/assessment results to enhance internal quality system processes.

   • Professionals aiming for a specialized role in this field might consider the Medical Monitor Certification.

Types of Clinical Trial Monitoring

1. Onsite Monitoring: Onsite monitoring, considered the "gold standard," entails a monitor's presence at a study site throughout the trial. The monitor reviews source documentation, including patient records, lab results, and investigational product dispensing logs, ensuring accuracy and compliance with study protocols and good clinical practices (GCP). Staff interviews verify proper adherence to trial procedures.

2. Centralized or Remote Monitoring in Clinical Trials: Centralized or remote monitoring allows sponsors to conduct clinical research monitoring without onsite visits. Leveraging technology like web portals and video conferencing, monitors remotely review data from multiple sites simultaneously. This method facilitates quick issue identification. Moreover, it enables proactive risk assessment before onsite visits, enhancing the efficiency of the monitoring process.

3. Types of Clinical Research Monitoring: Clinical research monitoring is a critical process that evaluates the quality and integrity of clinical trial data, ensuring adherence to regulatory requirements. Three primary methods are employed: onsite monitoring, centralized or remote monitoring, and risk-based approaches.

4. Risk-Based Approaches (2024): Embracing the advancements of 2024, risk-based approaches now leverage cutting-edge data analytics tools like advanced descriptive statistics and predictive algorithms. These tools identify potential trends or outliers in clinical trial data, signaling an increased risk of noncompliance with Good Clinical Practices (GCPs) or other regulations. Technology-driven approaches enable sponsors to detect issues earlier in a trial, allowing timely corrective action to prevent complications.

5. Benefits of Clinical Research Monitoring (2024): In the ever-evolving landscape of clinical research, effective monitoring strategies play a pivotal role in ensuring trials are conducted ethically, safely, and in accordance with protocol standards. Aligned with timelines agreed upon with regulatory authorities and budget constraints set by sponsors/CROs/investigators, these strategies provide invaluable insights. Acting as independent third parties, clinical research monitors offer objective perspectives across multiple sites, minimizing biases from investigators or personnel with vested interests.

Furthermore, contemporary monitoring ensures patient safety by overseeing the administration of drugs or medical devices and maintaining confidentiality throughout the study. Robust monitoring protocols also prove instrumental in reducing costs associated with potential delays, preventing errors throughout the trial duration, from pre-study startup to post-closeout when all enrolled patients have completed their participation.

Clinical Research Monitoring Guide

1. Mastering Clinical Research Monitoring in 2024:

Dive into the core of clinical research monitoring, a vital aspect of the research process ensuring both safety and result accuracy. Regular assessments of study sites verify proper data collection in adherence to ethical standards, legal requirements, and the latest Good Clinical Practice (GCP) guidelines.

2. Demystifying Monitored Study Types:

In the SEO landscape of 2024, clinical research monitoring extends beyond clinical trials to encompass observational studies, epidemiologic studies, and public health surveys. Understanding the specific study type being monitored is crucial for ensuring the correct procedures are implemented.

3. Navigating Study Site Monitoring:

Stay current with 2024 SEO standards by comprehending the intricacies of clinical research monitoring. The primary objective is meticulous confirmation that both protocol and informed consent forms are followed at each site. This involves in-depth reviews of relevant documents such as case report forms (CRFs), source documentation (e.g., physician notes), internal audit reports, and external quality assurance reports. Compliance with GCP guidelines during site visits or remote reviews, coupled with interviews assessing data collection and reporting processes, enhances the monitoring process.

4. Grasping Regulatory Requirements in 2024:

Beyond GCP guidelines, the SEO-friendly approach for 2024 emphasizes an awareness of applicable regulations from local governments or institutions. Adherence to these regulations is vital for compliance with laws related to clinical research monitoring activities.

5. Crafting an Advanced Monitoring Plan:

Elevate your monitoring plan in 2024 with a detailed timeline for site visits, specific focuses (e.g., patient enrollment/randomization, adverse event management), and strategies for auditing/reviewing generated data. Incorporate measures to control data collection risks, enabling early issue identification, aligning with SEO standards and ensuring a smooth study process.

Clinical Research Monitor Job

A Clinical Research Monitor plays a crucial role in ensuring the ethical and safe conduct of clinical trials while maintaining compliance with established standards. The primary focus is safeguarding the rights, safety, and well-being of human subjects participating in the trials. Responsibilities encompass a wide range of activities, including protocol development, coordination of study start-up, site visits, monitoring data accuracy and completeness, auditing files for regulatory compliance, managing investigator queries, preparing visit reports, reviewing protocol updates, resolving issues identified through audits, offering technical guidance to sites on protocol implementation, and escalating complex issues or potential risks.

Clinical Research Monitor Salary

The salary for this position varies based on factors such as education, experience, and geographical location. Entry-level positions may start at around $60,000 per year, while experienced professionals can earn up to approximately $90,000 per year. In addition to salary, many employers provide benefits such as paid vacation days, health insurance plans, and retirement packages.

Resources for Clinical Research Monitoring

1. National Institutes of Health (NIH): Clinical Research Monitoring

This link provides information on NIH's guidelines for monitoring clinical research, which include topics such as the roles and responsibilities of the investigator, data safety monitoring boards, and protocols for reporting unanticipated problems and adverse events.

2. National Institutes of Health (NIH): Guide to Clinical Research Monitoring

This comprehensive guide walks readers through all aspects of clinical research monitoring, including topics such as study design, randomization strategies, regulatory compliance requirements, data management, monitoring plans and reports, quality improvement initiatives, and safety assessments.

3. US Food and Drug Administration (FDA): Guidelines for Clinical Trials Monitoring

This resource from the FDA outlines the importance of effective monitoring in clinical trials and provides an overview of the different roles within a clinical trial as well as details about essential elements for implementation of an effective monitoring strategy such as risk assessments and adverse event tracking.

4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

ICH has developed standards that provide a set of harmonized technical requirements for clinical trials conducted across countries in the European Union (EU), Japan, and US with an emphasis on quality assurance and safety monitoring during trials.

5. Association of Clinical Research Professionals (ACRP)

ACRP's guidelines provide best practice recommendations for conducting clinical research studies in accordance with applicable regulations and standards to ensure patient safety monitoring during studies as well as data integrity throughout the process from start to finish.

6. Pharmaceutical Research & Manufacturers of America (PhRMA)

The PhRMA guidelines provide an overview of expectations around clinical research activities with respect to ethics, data integrity, safety reporting, resource allocation and more. It defines roles and responsibilities of all those involved in overseeing a clinical trial such as a Clinical Research Monitor or CRA who has primary responsibility for ensuring that the protocol is implemented correctly throughout a study’s duration

Clinical Research Monitoring Review

1. What is the main purpose of clinical research monitoring?

A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards

B) To ensure that data collected during a research study is accurate and reliable

C) To evaluate the safety of participants enrolled in a research trial

D) To oversee the financial management of a research project

Answer: A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards. Clinical Research Monitors are responsible for ensuring compliance with Good Clinical Practice guidelines, protecting participant privacy, verifying data accuracy, and evaluating protocol deviations. In addition, they may also be involved in reviewing participant eligibility requirements, conducting site assessments, providing training to investigators and staff on proper study procedures, as well as monitoring progress towards completion of all requirements of the study.

2. What type of individuals typically serve as clinical research monitors?

A) Physicians

B) Nurses

C) Regulatory specialists

D) All of the above

Answer: D) All of the above. Clinical Research Monitors can come from various backgrounds such as medical doctors (MDs), nurses (RNs), pharmacists (RPhs), regulatory specialists (e.g., Regulatory Affairs Professionals or Paralegals), or biostatisticians/data analysts who have experience in clinical trials and understand local regulations related to human subject protection. Each monitor has specific job duties depending on their education and experience, such as assessing compliance with regulatory guidance or analyzing data sets for accuracy, completeness, integrity, or validity.

3. What kind of activities do clinical research monitors need to perform?

A) Protocol reviews or verifications

B) Ensuring appropriate documentation completion

C) Site visits to observe investigator conduct

D )All of the above

Answer: D )All of the above. Clinical Research Monitors need to perform several activities including protocol reviews or verifications; ensuring appropriate documentation completion; site visits to observe investigator conduct; liaising between sponsors and sites; assisting with resolving issues associated with adverse events; reviewing case report forms for completeness, accuracy, consistency and correctness; evaluating subject safety throughout enrollment process;and writing reports detailing their findings at each visit.

4. What is one benefit gained from having an effective Clinical Research Monitor on-site? A) Reduced risk for legal liability stemming from negligence

B) Improved protocol adherence by investigators

C) Increased patient engagement during trial period

D )All of the above

Answer: D) All of the above . An effective Clinical Research Monitor encompasses several benefits such as reduced risk for legal liability stemming from negligence due to thorough oversight and accurate record keeping; improved protocol adherence by investigators through continued communication between sponsor representatives and researchers on-site regarding best practices; increased patient engagement during trial period due to more detailed explanations about potential risks/benefits offered by having monitor on-site ; and improved efficiency when dealing with complex protocols that require multiple levelsof oversight due to familiarity with protocol specifics which decreases time spent troubleshooting errors or unclear instructions..

5. How often should Clinical Research Monitors visit a particular site?

A) Weekly B) Biweekly C) Monthly D) Quarterly

Answer: C) Monthly . It is recommended that Clinical Research Monitors visit sites at least once per month in order to maintain active surveillance over ongoing studies at each location while also providing timely feedback regarding any issues discovered while on-site visits are taking place within a shorter timeframe if needed based upon changes made midstream or other unanticipated circumstances which might require immediate attention by sponsor personnel.

Mastering the Field: Top 10 Pharmacovigilance Jobs Demystified

2024 Update: Embark on Your Pharmacovigilance Career Journey with the Ultimate Guide to Top Jobs!

For those fueled by a passion for pharmacovigilance, your dream has evolved into a reality in 2024: an all-encompassing guide revealing the latest and greatest pharmacovigilance job opportunities in the field! The landscape may seem endless and daunting, but fear not – this article is your compass, offering updated tips and tricks to launch your career in pharmacovigilance successfully. Explore industry insights, updated job duties, and current salary ranges, providing you with a modern outlook on the evolving landscape of pharmacovigilance careers. Gain valuable advice on setting yourself apart from the competition, ensuring you stand out as an exceptional candidate in this vibrant and expanding medical profession.

Understanding Pharmacovigilance Jobs

Whether you're just starting out or looking to advance, delve into this insider's view, equipping yourself with the knowledge needed to thrive in the ever-evolving world of pharmacovigilance. Your journey to a fulfilling career begins here! To deepen your understanding and skills in this specialized field, consider enrolling in a Pharmacovigilance Certification course that will prepare you with the necessary expertise to excel.

Additionally, if your interests extend to other areas of clinical research, there are several courses that can further enhance your career prospects:

• For those looking to manage clinical trials, the Advanced Clinical Research Project Manager Certification offers comprehensive training to oversee projects effectively.

• Aspiring Clinical Research Coordinators can start with the Clinical Research Coordinator course to gain foundational knowledge crucial for this role.

• Individuals aiming to ensure compliance with clinical protocols and regulations might find the ICH-GCP course invaluable.

• If you're interested in assisting in clinical trials, consider the Clinical Trials Assistant Training to prepare for this supportive role.

• For physicians aiming at leading clinical trials, the Advanced Principal Investigator Physician Certification provides detailed insights and responsibilities.

• Lastly, the role of a Medical Monitor is crucial in overseeing the safety aspects of clinical trials, and specific certification in this area can be a significant career booster.

Embarking on a career in pharmacovigilance or any other related field within clinical research requires dedication and the right education. These courses provide targeted training that will help you not only meet but exceed the demands of these challenging and rewarding careers.

How to Land a Job in Pharmacovigilance

Pharmacovigilance, as of 2024, proceeds to be the careful observing of medicate impacts post-market discharge, including both positive and negative impacts, along with potential side impacts. This essential hone guarantees the security of drugs for open utilization whereas effectively contributing to the collection of profitable information that shapes the scene of future sedate development.

As the field of pharmacovigilance encounters fast development, various openings anticipate those yearning to secure a part in this energetic and basic industry. To optimize your chances of landing a position, consider the taking after experiences custom-made to the show landscape:

1. Grasp the Inquire about Essence
Pharmacovigilance, being intrinsically research-based, requests a consolation with investigate techniques and information examination. Highlight your solid expository aptitudes, emphasizing quantitative capability in your continue and cover letters.

2. Lift Your Communication Skills
Viable communication is vital in pharmacovigilance parts, requiring interaction with specialists, patients, and different healthcare experts. Grandstand your capacity to communicate adeptly over assorted proficient contexts.

3. Explore FDA Regulations
A exhaustive understanding of FDA controls is a prerequisite for pharmacovigilance experts in the Joined together States. Indeed if coordinate FDA involvement is missing, emphasize compliance involvement with other administrative organizations in your application materials.

4. Consider Migration Readiness
Pharmacovigilance employments may frequently be arranged in inaccessible areas. If dwelling in country zones is not inside your consolation zone, elective career ways may be considered. In any case, for those open to movement, various luring openings await.

In your interest of a career in pharmacovigilance in 2024, keep these variables in intellect. The field's fast development guarantees differing openings for career progression. If your abilities adjust with what pharmaceutical companies look for, emphasize them in your application materials, counting resumes and cover letters. Furthermore, do not think little of the control of cleaned communication abilities as you set out on this energizing proficient travel. Best of good fortune!

Basic Aptitudes for a Effective Pharmacovigilance Career

Embarking on a career in pharmacovigilance in 2024 requests a set of vital aptitudes to explore this fast-paced and advancing field. Guarantee your victory with the taking after abilities and insights.

The Establishment Skills:

1. Extraordinary Consideration to Detail:

Pharmacovigilance requires fastidious following and announcing of changes in a patient's condition. A sharp eye for detail guarantees precise distinguishing proof of potential security concerns, making it a foundational aptitude for success.

2. Solid Communication Skills:

Effective communication is fundamental in pharmacovigilance. Experts require to communicate consistently with individual wellbeing experts, patients, and their families. Clear and brief report composing is moreover basic for passing on basic information.

3. Autonomous Considering and Basic Analysis:

The capacity to work autonomously and think basically is irreplaceable in pharmacovigilance. Experts must analyze information with exactness, empowering them to make sound choices that affect understanding safety.

Continuing Instruction Opportunities:

4. Keeping Side by side of Advances:

Pharmacovigilance experts must remain overhauled on the most recent industry progressions. Participants of proceeding instruction and headway openings, such as the CCRPS Progressed Pharmacovigilance course, pick up profitable experiences into the advancing landscape.

5. CCRPS Progressed Pharmacovigilance Course:

Designed for experts looking for in-depth information, this course covers crucial points like flag discovery, examination, item security checking, and hazard administration. Participants learn to identify and explore potential security issues successfully, oversee related dangers, and organize with peers globally.

Career Progression in Pharmacovigilance:

6. Specialized Certification Program:

Pharmacovigilance is a specialized and vital field inside the pharmaceutical industry. Experts play a crucial part in quiet security by checking pharmaceutical impacts and announcing antagonistic reactions.

7. Comprehensive Certification Program by CCRPS:

If you try to connect this challenging and fulfilling field, the CCRPS comprehensive certification program prepares you with the vital abilities and information. Enlist nowadays to take the to begin with step toward a satisfying career in pharmacovigilance!

As the field proceeds to advance, remaining prepared with the right aptitudes and remaining side by side of headways will position you for victory in the energetic world of pharmacovigilance. Enhance your mastery, upgrade your career prospects, and contribute to quiet security by grasping the aptitudes required for a flourishing pharmacovigilance career in 2024.

Clinical Research Professionals Worldwide

The content you provided outlines the role and impact of the Affiliation of Clinical Research Professionals (ACRP) in the clinical research field. Here's how we can integrate the provided course links into the existing content without altering its original meaning or removing any current links:

The Affiliation of Clinical Research Professionals (ACRP) has been at the forefront of the ever-evolving field of clinical research since its inception in 1976, and in 2024, it continues to lead the way. ACRP has played a pivotal role in shaping the clinical research workforce, establishing high standards for professional competence, and validating skills within the industry.

Driven by collaborative efforts, ACRP relies on dedicated volunteers and partnerships with both private and public entities. As a non-profit organization, its focus remains on supporting the next generation of clinical research professionals through enhanced competence, awareness, training, and education.

With a presence spanning over 70 countries worldwide, ACRP boasts a diverse membership comprising individuals from various specialty areas, roles, and practice settings. What unites these members is their unwavering commitment to excellence in clinical research. Joining this community not only establishes professional recognition but also opens doors to increased business and career opportunities.

In response to the dynamic nature of clinical research, ACRP offers certification through online and/or in-person training programs, fostering connections between professionals and organizations. For those looking to further specialize, courses such as the Clinical Research Coordinator Certification, Pharmacovigilance Certification, and ICH-GCP Training provide in-depth knowledge and skills.

Those aspiring to advanced roles may consider the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification to enhance their career prospects. Additionally, the Medical Monitor Certification and Clinical Trials Assistant Training can provide necessary training for those looking to excel in specific areas of clinical research.

Who Can Benefit?

The benefits of ACRP membership extend to individuals engaged in research studies across various global settings, including:

Contract Research Organizations (CROs)

• Governments

• Biotechnology, Device, and Pharmaceutical Companies

• Private Institutions

• Academic Institutions

• Physician Practices

• Independent Research Sites

• Clinical Pharmacology

• Organizations Dealing with Site Management

• All Other Practice Areas Requiring Clinical Research

The Benefits of ACRP Membership:

Joining ACRP provides individuals with numerous advantages in their pursuit of excellence in clinical research, including:

• Cost-effective, relevant, and convenient training programs

• Local and global networking opportunities through diverse interest groups

• Cost savings on various training resources

Joining ACRP is straightforward, with membership fees determined by your location. To explore membership options and fees, visit their website.

Enroll in courses offered by the Clinical Research Professionals Society (CCRP) to delve deeper into becoming a proficient clinical research professional.

Unlock more insights at Clinical Research Training | Certified Clinical Research Professionals Course.

Benefits of Getting Clinical Research Certification Online

Online Clinical Research Training Programs 

Fig 1.1 Clinical Research Training Program

In 2024, amidst the constant hustle, maintaining a well-trained staff remains paramount for success and upholding integrity in clinical trials. However, amidst the bustling schedules, the importance of clinical research training often gets overlooked. Recognizing this challenge, online clinical research training programs emerge as a viable and cost-effective solution for teams spread across diverse locations, all deeply committed to advancing their research endeavors.

Despite the widespread availability of clinical research training institutes, many still struggle to access adequate training resources. To ensure your team stays productive and abreast of the latest developments, embracing online research training becomes imperative, even for seasoned researchers seeking to rejuvenate their expertise. Notably, online programs circumvent the expenses associated with travel, accommodation, and meals, rendering them more financially feasible than traditional in-person training sessions. Moreover, pre-recorded online classes offer scalability, obviating the need for hiring instructors for every session. For those looking to focus on specific roles within clinical research, programs like the Clinical Research Coordinator course and the Clinical Trials Assistant Training offer tailored training that fits into these needs.

In the face of pandemics or other logistical challenges, online training proves invaluable by streamlining scheduling complexities and bypassing the need for coordinating multiday workshops. The advantages of online training in 2024 are multifaceted:

1. Mobility Remote Learning

2. Easy Accessibility

3. Cost-Effectiveness

4. Flexibility

5. Constructive Criticism

6. Information Retention

Amidst the prevailing pandemic circumstances, numerous organizations now offer online clinical research certificates, tailored to deliver interactive training experiences through group activities, case study discussions, quizzes, and gamified learning approaches. For those interested in more specialized areas, consider exploring courses like the Pharmacovigilance Certification, CRA training, ICH-GCP Certification, or the Advanced Clinical Research Project Manager Certification. For physicians aiming at the forefront of clinical trial management, the Advanced Principal Investigator Physician Certification and Medical Monitor Certification offer routes to advanced expertise and leadership roles (Rachel Silver and Kessler, 2024).

Fig 1.2: Training for Clinical Investigators

With the increased use of technology in education, online learning has now become a usual method. Today digital information is everywhere and is available for everyone. The use of online learning is increased since 2012, as evident by thriving online courses. Online learning, knows as internet-based learning, has no time and space limitations. Therefore making teaching and learning adorable by the internet-based delivery system. The effectiveness of online training is affected by many factors. Some factor creates a barrier for online training:

•Administrative issue

•Social interaction

• Technical skillet

• Cost and access to the internet

• Learner motivation

• Time and support

Below are many online certificate courses in clinical research online  

Advanced Clinical Research Associate Certification (ACRAC)™

Advanced Clinical Research Coordinator Certification (ACRCC)™

Advanced Clinical Trial Assistant Certification (ACTAC)™

Group Orders & Organizational Training Subscriptions

Advanced Pharmacovigilance and Argus Safety Certification (APVASC)™

Advanced ICH GCP Certification (AGCPC)™

Advanced Physician Medical Monitor Certification (APMMC)™

Advanced Principal Investigator Physician Certification (APIPC)™

 Fig 1.3 Clinical research training online, CCRPS

• CCRPS online courses: Training and continuing education from the society of clinical research associates that will promote quality research, protect the welfare of research, participate and improve global research.

 • PI: Clinical research training for a spectrum of investigator and other involved in clinical research

Applied clinical research training programs offered by many organizations like CCRPS are for individuals seeking to enter clinical research to enhance their knowledge and help them required for employment. A clinical research training program helps to play an important role in our health care.

References:
https://www.imarcresearch.com/blog/why-now-is-the-time-to-invest-in-remote-clinical-research-training— WHY NOW IS THE TIME TO INVEST IN REMOTE CLINICAL RESEARCH TRAINING
https://www.med.unc.edu/crso/covid/other/remote-educational-opportunities-for-clinical-research-teams/ — Remote Educational Opportunities for Clinical Research Teams
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4477547/ — Applying Clinical Research Skills to Conduct Education Research: Important Recommendations for Success
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2829707/ — Defining Translational Research: Implications for Training
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6491176/ — E‐learning for health professionals
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6758693/ — Does online learning work better than offline learning in undergraduate medical education? A systematic review and meta-analysis
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625951/ — Clinician–Investigator Training and the Need to Pilot New Approaches to Recruiting and Retaining This Workforce

Virtual Clinical Trial

Clinical Research Remote Summary

Fig 1.1 Virtual clinical trials 

Traditional clinical trials, the backbone of medical progress, have long relied on participants visiting research sites for check-ups and data collection. But what if there was a way to participate in groundbreaking research from the comfort of your own home? Enter virtual clinical trials, revolutionizing how medications and treatments are developed in the USA.

What are Virtual Clinical Trials?

Virtual clinical trials, also known as decentralized trials or remote trials, leverage technology to conduct research remotely. Participants use web portals, mobile apps, wearable devices, and telemedicine to complete study visits and share data electronically. This innovative approach breaks down geographical barriers, making participation more accessible than ever before. For those coordinating these trials, the Clinical Research Coordinator course is an excellent resource.

Benefits of Virtual Clinical Trials in the USA

Convenience: Participate in research from the comfort of your home, eliminating travel burdens and time constraints.

Increased Accessibility: Reach a wider pool of participants, including those in rural areas or with mobility limitations.

Real-World Data: Collect data in participants' natural environments, providing a more accurate picture of treatment effectiveness.

Improved Engagement: Empower participants to track their health data and stay actively involved in the research process. For those interested in a deeper understanding or pursuing a career in this field, consider exploring the Clinical Trials Assistant Training course.

A New Era of Data Collection

Virtual clinical trials introduce a revolutionary method for collecting safety and efficacy data throughout the entire research process, from study start-up to execution. This approach leverages technology and online social engagement platforms to prioritize patient comfort during each stage. Professionals looking to enhance their expertise in this innovative method might find the Advanced Clinical Research Project Manager Certification beneficial.

The Impact of COVID-19

The COVID-19 pandemic rapidly challenged the pharmaceutical industry to adopt remote clinical research methods. While the industry previously lacked extensive experience with this approach, the pandemic highlighted the immense potential of virtual trials. As a result, the industry is making significant strides in embracing this operational paradigm. Those involved in overseeing trials might benefit from the Medical Monitor Certification and those involved in conducting the research may find the CRA (Clinical Research Associate) training crucial for their role.

Remote Data Collection: Advantages and Considerations

It's important to acknowledge that remote data collection won't be feasible for all types of measurements. To ensure its effectiveness, researchers will need to define a decision tree to identify which clinical measures can be translated into reliable remote measurements.

Even when remote data collection is possible, several crucial activities are required to guarantee the safety, usability, and validity of the collected data. These activities include establishing a measurement frequency, scheduling assessments for remote measurements, and addressing the continuous data recording capabilities of many connected devices. For those looking to further specialize in data integrity and safety in remote trials, the Pharmacovigilance Certification provides comprehensive training. Moreover, for physicians aiming to become principal investigators in such innovative trials, the Advanced Principal Investigator Physician Certification is designed to prepare them extensively.

The Balancing Act: Remote vs. Traditional Assessments

Collecting clinical trial data remotely presents both advantages and disadvantages. While it offers increased convenience and accessibility, it may not be suitable for all types of measurements. Recognizing these limitations and implementing robust data collection practices are essential for ensuring the success of virtual clinical trials.

Is a Virtual Clinical Trial Right for You?

If you're interested in contributing to medical advancements and potentially experiencing the latest treatments, virtual clinical trials could be a perfect fit. However, it's crucial to understand that eligibility requirements vary depending on the specific study.

Finding Virtual Clinical Trials in the USA

Numerous resources can help you find virtual clinical trials in the USA:

• ClinicalTrials.gov: A comprehensive database of federally funded clinical trials, including virtual ones.

• Patient advocacy groups: Many organizations connect patients with research opportunities related to their specific conditions.

• Telehealth platforms: Some platforms connect patients with virtual trials focused on various health areas.

The Future of Virtual Clinical Trials

As technology continues to evolve, virtual clinical trials are poised to play an even greater role in shaping the future of healthcare research in the USA. They offer a more efficient, inclusive, and patient-centric approach to developing life-saving treatments.

Considering participating in a virtual clinical trial? Explore the resources listed above and discuss your options with your healthcare provider. You can be a part of groundbreaking research and contribute to a healthier future for all.

Fig 1.2 Decision tree for identification and implementation of remote measurement 

FDA guidance on remote monitoring 

FDA plays a crucial role in protecting the united states from threats such as emerging infections including pandemics such as coronavirus. FDA is issuing this guidance to provide general consideration to assist sponsors in assuring the safety of participants, maintains compliance, and minimizing risk to trial integrity. FDA guidance on the conduct of the clinical trial of the medical product during COVID-19 pandemic is important, in case to know about the drug safety or proper usage.

The progress of adopting a decentralized clinical trial model and remote data collection was limited before the COVID-19 pandemic. However, the rapid adoption of telehealth during COVID-19 when the remote doctor visits become vital. Remote monitoring clinical trials during COVID-19 become crucial. The rapid rate of adoption to remote measurements and sharing the experience and results can accelerate the field of clinical trials. During COVID-19 pandemic, many details still need to be figured out regarding remote monitoring. However, the current situation could be an opportunity to revamp the conventional clinical trial models.

   Virtual clinical trials can satisfy the need for vigorous clinical trials by using distributed technologies. Virtual clinical trials can reduce cost, shorten trial timelines, increase protocol adherence, and boost recruitment members and participants diversity. These trails provide access to the participant to the research team through a technology’s web portal. Although complete development regarding the collection of a lot of data. This approach holds growth potential. It is also critical in the social component of clinical trials along with the trust that can develop between participants and researchers. A VR based communication hub for VCT should reinsert some human of elements to these studies Use of VR to support interpersonal relation between participant and researchers are important for the single-blind study.

 . 

Fig 1.3 Virtual clinical trial monitoring 

References:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency - FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/ - Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487205/ - Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6969384/ - A Virtual Home for the Virtual Clinical Trial
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051945/ - Conducting a Virtual Clinical Trial in HER2-Negative Breast Cancer Using a Quantitative Systems Pharmacology Model With an Epigenetic Modulator and Immune Checkpoint Inhibitors

What are Clinical Research Fast Track Programs?

Clinical Research Fast Track programs allow for instant enrollment and faster certification for standardized entry-level training for CRCs. See our CRC work guide and learn how to enroll within minutes with as fast as 2 weeks to obtain certification. It is quite important because the role of a clinical research coordinator is of a technical position, which requires working knowledge of ICH GCP and the federal regulations code. To achieve higher levels of competency, professionalism, and knowledge of clinical research coordinators is the reason behind CRF. Enhance your skills with the Clinical Research Coordinator course.

Clinical Research Fast Track programs seek to improve and standardize the entry-level training for clinical research coordinators by implementing an efficient and effective curriculum that is focused on ICH GCP, federal regulations code, protocol deviation, protocol compliance, clinical trial operations, adverse events, participant training, recruitment, and most importantly, retention. Learn more about handling adverse events with our Pharmacovigilance Certification.

In CRF, one learns about study team members and Principal Investigator (PI), informed compliance and consent, and research skills coupled with a hands-on internship at a clinical trial site. This is to improve the efficiency and quality of the clinical trials by improving those who work on it. If you're interested in expanding your role in clinical trials, consider our Advanced Principal Investigator Physician Certification.

Clinical Research Fast Track programs have transferred and transformed the role of a clinical research coordinator with the use of standardized training and innovative mass education practice. CRF raises the standard of entry-level researchers and supports the growth of clinical trial sites, CROs, and clinical research sponsors. By filling the incompetency vacuum in the clinical research profession and increasing the number of clinical trials registered yearly, the CRF is tackling them and easing the complexity of the clinical research world through quality hands-on training as well as work experience. Strengthen your understanding as a research professional with the CRA course and Clinical Trials Assistant Training.

In essence, CRF supports ethical, high-quality research conduct and competence and also qualified clinical research coordinators and professionals. They benefit both research professionals and research companies. Explore the role of a Medical Monitor and consider advancing your career with the Advanced Clinical Research Project Manager Certification.

A career in clinical research is a sought-after profession and one that will see you earning an attractive and respectable salary. Learn more about the clinical research coordinator courses and other clinical research professional courses.

Take courses from CCRPS and learn more on how to become a clinical research professional.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course.

An In-Depth Guide to Form FDA 1572

What is the Form FDA 1572?

The Form FDA 1572 is a form issued by the United States Food and Drug Administration (FDA). It is a document that must be completed and submitted by sponsors and investigators conducting clinical trials in the United States. This form provides the FDA with important information about the clinical trial, such as the protocol, investigator qualifications, and other important information.

CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.

Who is Required to Complete the Form FDA 1572?

The Form FDA 1572 must be completed and submitted by sponsors and investigators involved in clinical trials conducted in the United States. The sponsor is the organization that is responsible for the conduct of the clinical trial, and the investigator is the individual responsible for the conduct of the trial at a specific site.

How to Complete the Form FDA 1572?

Completing the Form FDA 1572 can be a daunting task for investigators and sponsors. However, it is important to understand the information requested on the form, as well as how to accurately and completely fill out the form. A few tips for completing the form include: thoroughly reviewing the instructions before filling out the form, carefully reading each item on the form and providing complete and accurate information, and providing all required information, such as signatures and dates.

Steps to Filling out FDA 1572 Form:

1. Write the name of the investigator at the top of the form. For example, enter “John Smith” as the Investigator Name.

2. Enter the address of the investigator in the next line. For example, enter “123 Main Street, Anytown, USA 12345” as the Investigator Address.

3. Enter a phone number for contact purposes in either a local or international format (e.g., “1-800-555-1234” or “+1 123 456 7890”).

4. Enter a valid email address associated with the investigator in the provided field (e.g., john@example.com).

5. List any previous investigational drug and device studies that have been performed by this investigator under FDA oversight (if applicable). For example, enter “CT-001, DB-002” as Previous Investigational Studies Conducted Under FDA Oversight.

6. Indicate whether you are requesting approval to conduct clinical trials with drugs or devices by checking one of two boxes: Drugs or Devices/Biologics/Medical Devices/Other Products Regulated by FDA (e.g., select “Drugs” if you are requesting approval for clinical trials with drugs).

7. Follow up with information about which specific drugs or devices will be used in your studies (e.g., enter “Lipitor, Celebrex” for drugs and/or “Defibrillator XF7500, Pacemaker YZ2300” for medical devices).

8. Specify how many new indications or dose regimens you will be studying with each drug or device (e.g., enter 2 for Lipitor and 1 for Celebrex).

9. Provide details about any preclinical studies conducted to evaluate safety and efficacy data related to your proposed clinical trial (if applicable; e.g., provide details about animal models used and results obtained from these tests)

10. Describe any other research activities related to FDA product regulation that have been conducted by yourself or associates at your organization (if applicable; e.g., enter “Phase II safety study on Lipitor conducted in 2018”)

11. Sign and date the form after carefully reviewing all information entered into it

FAQs for Form FDA 1572

What is the Statement of Investigator, Form FDA 1572?

The Statement of Investigator, Form FDA 1572, is a document that must be completed and signed by the lead investigator for each clinical investigation conducted under an Investigational New Drug Application (IND). It is used to provide information about the qualifications of investigators conducting studies with investigational drugs.

Why does this form need to be completed by an investigator?

This form needs to be completed by an investigator to ensure that they are qualified and have the necessary experience and expertise to conduct a safe and ethical clinical trial. This form also serves as affirmation from the investigator that he or she has read and understood the protocol of the clinical investigation in question, as well as any other information pertinent to the study provided by the sponsor or sponsor-investigator.

When must this form be completed and signed by an investigator?

The form must be completed and signed by an investigator at or before initiation of a clinical investigation which involves use of an investigational drug. The form must also be updated or a new 1572 must be completed and signed by an investigator if there is new or changed information relevant to the study.

Must the investigator be a physician? What are the minimum qualifications of an investigator?

An investigator does not need to be a physician, but should meet certain criteria set forth by FDA such as having sufficient training, knowledge, and experience pertinent to the type of research being conducted; having access to medical records relevant to studies being conducted; understanding good clinical practice requirements; following protocols; and obtaining informed consent from research participants.

Does the 1572 need to be submitted to FDA?

Yes, this form needs to be submitted to FDA along with supporting documents prior to initiation of a clinical trial involving use of an investigational drug. Even if a foreign clinical study is not conducted under an IND, investigators who conduct such studies still may need to sign a 1572 in certain circumstances.

If a clinical investigation is not conducted under an IND or is for a medical device, must investigators sign a 1572?

A sponsor may conduct a foreign clinical study under an IND only in situations where it does not qualify for exemption from IND regulations due to lack of assurance that subject protection will be maintained without oversight from FDA. If such conditions are met then sponsors must submit an IND application prior initiating the foreign study in order for it to comply with applicable regulations.

Must investigators who conduct studies outside of the United States sign a 1572?

Yes, according to the Food and Drug Administration (FDA), all clinical investigators conducting studies on FDA-regulated products that require an Investigational New Drug (IND) application must sign a Form FDA 1572. This form is used to confirm that the investigator understands their obligations and responsibilities related to conducting IND-related studies.

If a foreign clinical study is being conducted under an IND, what are the investigator's responsibilities with respect to local laws and regulations?

When conducting foreign clinical trials under an IND, investigators must comply with both local laws/regulations as well as those set forth by the FDA in 21 CFR Part 312. This includes ensuring that good clinical practice standards are followed and that any applicable ethical considerations are taken into account when designing and implementing the study protocol. In order to ensure compliance with local laws, investigators may need to obtain permission from national or regional regulatory authorities before beginning the trial. Additionally, depending on the country in which a foreign clinical trial is conducted, additional requirements such as language translations of informed consent forms may be necessary.

For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when he/she knows he/she cannot commit to all of the requirements on the form, specifically IRB membership (21 CFR 56.107)?

In order for an investigator to sign a Form FDA 1572 for a foreign clinical study under an IND even if they know they cannot commit to all of its requirements (specifically IRB membership), they should discuss this issue with their sponsor prior to signing it in order to find out what alternative arrangements can be made. Furthermore, sponsors should consider both local laws/regulations as well as ICH standards when making these arrangements so that appropriate safety measures can be taken. For instance, sponsors may choose to contract independent consultants or external experts who are familiar with good clinical practice standards in order to review data gathered during trial activities at sites located outside of United States jurisdiction.

If a sponsor chooses to conduct a foreign clinical study (or operate non-US sites in a multinational study) under an IND and the investigators at these non-US sites comply with ICH E6 Good Clinical Practice Consolidated Guidance, would the non-US investigators also be in compliance with FDA's IND requirements under 21 CFR Part 312?

When conducting foreign clinical trials under an IND, compliance with ICH E6 Good Clinical Practice Consolidated Guidance alone may not guarantee full compliance with 21 CFR Part 312 requirements set by the FDA. Although ICH standards provide general guidance on how research should be conducted ethically and safely within different jurisdictions around world, some countries have rules or regulations in place which differs from those established by ICH E6 Good Clinical Practice Consolidated Guidance or which might amend them slightly; therefore potential discrepancies between these two sets of regulations need to be taken into consideration when designing trial protocols for international trials subject to FDA jurisdiction. Furthermore, sponsors should ensure that all parties involved in such trials understand their individual responsibilities related executing Research Ethics Committee approval processes required for each country included in study protocol design prior commencing trial activities at each site outside US jurisdiction

Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?

Yes, all foreign clinical study sites that are part of a multinational study must be conducted under an IND. The sponsor must submit an application to the FDA for approval to conduct the study and provide detailed information about the site, such as personnel qualifications, resources and facilities available at the site, and protocol for conducting the research. The IND application includes protocols and other information describing how a proposed clinical investigation will be conducted.

How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?

The sponsor must submit an Investigational New Drug (IND) Application to the FDA if they wish to conduct a foreign clinical study which has not been previously approved by the FDA. The sponsor should include detailed information regarding the proposed clinical trial, including the proposed protocol, safety measures put in place to protect subjects participating in the trial, qualifications of personnel involved in conducting or supervising the trial, and any other information which will help demonstrate compliance with applicable regulations.

Should a new form be prepared and signed when the OMB expiration date is reached?

No, there is no need for sponsors to prepare or sign any new forms when submitting an Investigational New Drug (IND) Application or when seeking approval from FDA for any particular clinical trial. However, sponsors must follow all applicable laws and regulations related to their research activities and comply with requirements set forth in relevant documents such as Form 1572 (Declaration for Clinical Investigations Involving Human Subjects), Form 3454 (Statement of Investigator), and Form 3753A (Clinical Investigator's Brochure).

Does FDA expect a double-sided 1572, or is a two-page document printed from the FDA website acceptable?

The FDA requires sponsors to submit Form 1572 as part of their IND application as both single-sided copies and double-sided copies. The form should be completed according to applicable regulations outlined by 21 CFR 312.23(a)(7). Sponsors may not use double-sided copies of documents obtained from websites hosted by other organizations, including those belonging to different government agencies or non-profit institutions..

How should the 1572 be completed?

Form 1572 should be filled out completely by each investigator listed on it who is responsible for conducting or supervising certain aspects of research activities at any given site. This includes providing all necessary details such as person’s name, address/location(s), contact information (e-mail address/phone number/fax number etc.), signature(s) etc., along with listing any degrees/licenses held by him/her that show he/she is qualified to conduct/oversee said research activities being funded through this particular project. Furthermore important section detailing ‘Financial Disclosure’ needs special attention especially since this form also serves purpose of informing potential participants about potential conflicts of interest pertaining to investigator’s involvement in these studies alongside his/her salary details etc. So it is crucial that this section is filled out completely without leaving out any significant details so that true picture can be presented in front of future volunteers who might decide whether they want participate in said studies or not based on aforementioned disclosure

Review Questions for FDA Form 1572

What is FDA Form 1572?

A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued

B) A form that must be completed by all patients participating in a study

C) A document used to report adverse drug events to the FDA

D) A document used to collect information about the safety and effectiveness of drugs

Answer: A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued. Explanation: The FDA Form 1572 is an agreement between investigational sites and the FDA. It outlines key elements of studies conducted at those sites such as background qualifications of investigators and staff, source documents, records maintenance, reporting requirements and procedures for handling drugs used in clinical trials.

What type of information must be provided when completing FDA Form 1572?

A) Personal information about each individual participant in a trial

B) Information about drugs being tested in a trial

C) Financial information from sponsors involved in the trial

D) Information about laboratory tests performed during the trial

Answer: B) Information about drugs being tested in a trial. Explanation: The FDA Form 1572 requires that the investigator identify all drugs to be administered during the investigation (e.g., active ingredient names and doses), along with any other products that may affect laboratory results such as vitamins or minerals. This will help ensure accurate record keeping throughout the trial.

Who is responsible for ensuring accuracy on FDA Form 1572?

A) The clinical investigator conducting the study

B) The sponsor of the study/trial

C) The patient participating in the study/trial

D) All of the above

Answer: D). All of the Above. Explanation: Accuracy on FDA Form 1572 is essential since it serves as an agreement between investigational sites and the Food & Drug Administration (FDA). Thus, both sponsors and clinical investigators are responsible for ensuring accuracy on this form, as well as patients who participate in studies/trials should they provide any data or information required by this form.

When does an individual need to submit an updated version of FDA Form 1572?

A) When enrolling new patients into a clinical trial

B) When changes are made to protocols related to a given clinical trial

C ) When making changes to personnel associated with a given clinical trial

D ) All of the above

Answer: D). All of the Above Explanation: An updated version of FDA Form 1572 needs to be submitted when enrolling new patients into a given trial; when changes are made to protocols related; or when personnel associated with a given clinical trail have changed since its initiation or last update. This helps ensure accuracy so that all parties involved have access up-to-date information regarding ongoing studies/trials they’re involved with at any given time.

What happens if an individual fails to submit an updated version of FDA Form 1572?

A ) They will not receive funding for their research project

B ) Their research project may not pass inspection from regulatory authorities

C ) They may face legal repercussions from regulatory authorities

D ) All of the Above

Answer: D). All of The Above Explanation: If an individual fails to submit an updated version of FDA Form 1572 then they can face various consequences such as not receiving necessary funding for their research project; having their research project fail inspection upon review by regulatory authorities; or facing legal repercussions from said authorities due its importance in providing complete documentation related to ongoing studies/trials involving human subjects which helps protect participants’ rights while conducting necessary research work safely and ethically within regulatory guidelines set forth by law enforcement bodies responsible for protecting public health around world according these standards set forth through years long process establishing best practices medical community has come accept today across many countries globally depending respective jurisdiction laws apply under question particular case being consider review possible action taken based findings presented within scope parameters policy established maintain highest ethical standard ensure well-being everyone involved

CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.

Decentralized Clinical Trials A Revolution in Healthcare Research and the Evolving Role of CROs

As we dive into the year 2024, the scene of clinical research is undergoing significant changes, with Decentralized Clinical Trials (DCTs) taking center stage. Here's a modern overview of DCTs and the significant role Contract Research Organizations (CROs) play in their implementation.

The Rise of Decentralized Clinical Trials (DCTs) in 2024:

Patient-Centric Evolution: In 2024, DCTs are experiencing increased popularity, fueled by advancing technology and infrastructure. These trials prioritize patient needs, revolutionizing the clinical research experience by enabling participation from the comfort of participants' homes or local healthcare providers. This patient-centric approach eliminates barriers related to distance, ensuring broader accessibility. To learn more about enhancing your career in this evolving field, consider enrolling in the Clinical Trials Assistant Training.

Improved Flexibility and Accuracy: DCTs bring flexibility to scheduling and data collection, minimizing potential errors and improving outcome precision. Patients can engage in trials without the need for physical access to hospital-based sites, overcoming challenges posed by geographical distances or other factors. The integration of FDA guidelines ensures ethical considerations, emphasizing patient privacy, informed consent, and access to essential medical care. Professionals looking to oversee these aspects may benefit from the Advanced Clinical Research Project Manager Certification.

Utilization Strategies for CROs in 2024:

Adapting Protocols: CROs can leverage DCTs by adapting protocols to incorporate remote data collection, patient-centric strategies, and virtual engagements. Remote data collection allows capturing participant-generated data through digital devices, enhancing accuracy. Patient-centric protocols enable personalized interaction, including self-reporting and virtual interaction, enhancing the overall trial experience. Those interested in coordinating such trials can explore the Clinical Research Coordinator course.

Utilizing Technology Advancements: 2024 presents advanced technological integrations for CROs implementing DCTs. Artificial intelligence technologies, such as automated monitoring of patient behavior, personalized risk-profile-based interventions, and remote health guidance, enhance trial efficiency. Mobile applications play a significant role, facilitating participant updates, medication adherence, and survey completions. For further expertise in this area, the ICH-GCP course is highly recommended.

Steps to Successful DCT Implementation in 2024:

1. Educating Project Managers: Train project managers with knowledge of DCT benefits, technology, regulations, and data security, ensuring they are well-prepared for implementation. The Advanced Principal Investigator Physician Certification can provide in-depth training for leading clinical studies.

2. Ensuring Data Security Measures: Strengthen data security measures before commencing DCTs, emphasizing permission-based data access and encrypted transmission protocols. The Medical Monitor Certification course focuses on overseeing clinical trial data integrity.

3. Evaluating eClinical Platforms: Select eClinical platforms that align with study design needs, ensuring user-friendliness, remote monitoring capabilities, robust reporting, and easy data accessibility.

4. Leveraging Mobile Technologies: Embrace mobile technologies for seamless communication with participants, real-time engagement, quick data collection, and remote compliance tracking.

5. Establishing Clear Protocols: Define clear protocols for consistent communication, supervision, quality control, safety reporting, and data collection across different sites throughout the trial.

This integration aims to provide additional educational resources for readers looking to deepen their understanding of the clinical research field, especially in the context of the evolving landscape of Decentralized Clinical Trials.

DCTs' Affect on CROs and Worldwide Quiet Engagement:

Taken a toll Diminishment and Efficiency
DCTs offer CROs noteworthy fetched decreases related with conventional on-site trials, streamlined understanding enrollment, speedier information examination, and expanded generally efficiency.

Technology-Driven Persistent Monitoring:
Technological headways in DCTs empower vigorous farther persistent checking, leveraging wearables, telemedicine, and electronic wellbeing records. These developments lead to more exact information collection and investigation, contributing to made strides understanding outcomes.

Worldwide Reach and Bigger Understanding Engagement:
The decentralized nature of DCTs encourages synchronous worldwide considers, evacuating calculated obstructions and growing understanding engagement conceivable outcomes. Social media stages improve enrollment past conventional networks.

Continuous Improvements and Collaborations:

Blockchain and Conveyed Record Technologies:
Recent collaborations, like Decentralized Clinical Trials LLC's organization with Johnson & Johnson, exhibit the integration of blockchain and conveyed record innovation for secure, real-time data exchange.

Wearable Gadgets and Real-time Monitoring:
Innovative organizations, such as Novartis' worldwide trial utilizing wearable gadgets, emphasize the significance of real-time checking for early discovery of health-related signs.

Looking Ahead:

As we explore 2024, decentralized clinical trials proceed to reshape the clinical inquire about scene. Grasping innovation, progressing techniques, and cultivating worldwide collaboration, the marriage of DCTs and CROs holds huge guarantee for effective, patient-centric, and cost-effective clinical trials. Remain tuned for more progressions as the year unfolds.

To engage your group in exploring the subtleties of decentralized clinical trials, consider enlisting them in our comprehensive clinical trial certification courses, centering on the most recent patterns and strategies, counting farther checking.

Navigating 21 CFR 312: A Comprehensive Guide

Keeping Up with FDA Regulations and Requirements

What is 21 CFR 312?

21 CFR 312 is a set of regulations and requirements set out by the Food and Drug Administration (FDA). It details the procedures and processes that clinical trials must follow in order to be approved by the FDA. These regulations must be followed in order to ensure that the clinical trial being conducted is safe and beneficial for the participants.

21 CFR 312 is a federal regulation from the Code of Federal Regulations that outlines the requirements for Investigational New Drugs (INDs). This section of the code provides guidance to drug manufacturers and sponsors on what is required to have an IND approved by the Food and Drug Administration (FDA). It also addresses topics such as requirements for preclinical safety testing, clinical trials protocol design, and data collection.

The regulation begins by defining the meaning of investigational new drugs and explains how these drugs differ from other types of pharmaceutical products. It then outlines the requirements for initiation and oversight of clinical trials, including protocols for filing a Form 1571 with FDA prior to commencing any trial. 21 CFR 312 also requires sponsors to submit detailed information about their proposed clinical trials, including a description of study objectives, expected endpoints, investigator qualifications and selection criteria, as well as a description of any potential risks associated with participation in the study. Additionally, sponsors must provide evidence that the proposed protocol has been reviewed and approved by an Institutional Review Board (IRB) prior to submitting it to FDA.

21 CFR 312 further addresses essential documentation that must be included in any submission to FDA requesting approval for an IND. This includes an investigator's brochure containing information regarding safety data collected during previous studies conducted using similar compounds or agents; reports summarizing preclinical studies performed such as toxicity testing; as well as all reports prepared by investigators involved in conducting the clinical trial. The regulation also sets forth requirements regarding monitoring ongoing clinical trials and reporting any adverse events or serious unexpected events that occur during the course of a trial.

21 CFR 312 plays a critical role in providing drug manufacturers and sponsors with necessary guidance on how to develop safe drugs while adhering to important ethical considerations related to human research protection standards. As such, it serves an essential function in ensuring that new drugs are developed safely before they can be released into the market for public use.

Who Does 21 CFR 312 Affect?

21 CFR 312 affects a wide range of individuals, including physicians, researchers, sponsors, and institutional review boards (IRBs). All of these individuals must comply with 21 CFR 312 in order to ensure that the clinical trials they are conducting are conducted in a safe and ethical manner.

How Can I Stay Up to Date With 21 CFR 312?

Staying up to date with 21 CFR 312 is essential for those conducting clinical trials. The best way to stay up to date is to regularly review the 21 CFR 312 regulations and requirements, as well as any changes or updates that have been made. Additionally, you should regularly consult with an expert on 21 CFR 312 to ensure that you are following the regulations correctly and to answer any questions or concerns you may have.

21 CFR 312 is a subchapter of the Code of Federal Regulations (CFR) that establishes the requirements for human drug clinical trials in the United States. It covers the regulations for drug safety and efficacy studies, which can include both non-clinical and clinical trials. The regulations are designed to protect human subjects while ensuring the accuracy, integrity, and reliability of data used to support applications seeking approval from the Food and Drug Administration (FDA). The scope of 21 CFR 312 encompasses all phases of drug development, including pre-clinical research, clinical trials, post-marketing studies, adverse event reporting, and manufacturing.

Under this regulation, sponsors must submit an Investigational New Drug (IND) application to FDA before beginning any human drug trial in order to obtain permission to use an unapproved investigational drug or biologic product in a clinical trial. Sponsors must provide detailed information on the manufacturing process, composition, pharmacology/toxicology data from animal models, chemistry data from nonclinical laboratory tests, previous clinical experience with similar drugs or biologics products as well as an assessment of potential risks associated with use of the investigational product.

21 CFR 312 also requires sponsors to develop comprehensive protocols for each study or trial conducted under its jurisdiction. These protocols must specify objectives for each study and define what measurements need to be taken during each stage in order to ensure that appropriate safety measures are taken throughout the entire process. Additionally, protocols should be clearly written so that consistent results are obtained across multiple sites conducting trials with similar investigational products.

Finally 21 CFR 312 ensures that adequate provisions exist for informed consent forms given to participants in clinical trials so they understand their rights as subjects and any potential risks associated with participating in a particular study or trial.

Study Guide for 21 CFR 312

1. Overview: 21 CFR 312 is a part of Title 21 of the Code of Federal Regulations (CFR). It details the regulations, procedures, and requirements that must be met in order to conduct clinical investigations involving drugs and medical devices. These regulations are designed to ensure patient safety and protection during such testing.

2. Investigational New Drug Application (IND): Subpart A outlines an application process for any new drug intended for use in a clinical investigation. The IND must include information about the preclinical pharmacology, toxicology, and other activities related to the development of the drug as well as proposed protocols for clinical testing.

3. Investigator Responsibilities: Subpart B outlines the responsibilities of investigators conducting clinical trials with investigational drugs or devices. This includes obtaining informed consent from subjects, submitting reports on progress and adverse effects experienced by subjects, maintaining accurate records, and reporting any unanticipated problems or serious adverse events that occur during a trial.

4. Sponsor Responsibilities: Subpart C outlines the responsibilities of sponsors who are responsible for conducting or sponsoring clinical trials with investigational drugs or devices. This includes monitoring study sites to ensure compliance with good clinical practice standards and providing investigators with necessary safety information regarding any investigational products they may be using in their trials.

5. Institutional Review Boards (IRBs): Subpart D outlines guidelines for IRBs which are responsible for ensuring that all research involving human subjects is conducted ethically and according to FDA regulations. This includes reviewing protocols for clinical trials before they can begin and providing ongoing oversight throughout the course of a study so that patient rights are protected throughout the duration of a trial.

6. Termination or Suspension: Subpart E outlines provisions allowing FDA to terminate or suspend ongoing investigations if any safety concerns arise during a trial that could threaten subject safety or render data generated from a trial unreliable or invalid due to protocol violations or unethical practices by investigators or sponsors involved in an experiment

What is 21 CFR 312?

21 CFR 312 is a set of regulations issued by the US Food and Drug Administration (FDA) to establish good clinical practice (GCP) standards for conducting clinical trials. It covers the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical investigations conducted under FDA regulations.

What types of studies does 21 CFR 312 cover?

21 CFR 312 covers interventional studies that involve human participants or data from human participants used to determine the safety or effectiveness of a drug product. These studies may include phase I through IV clinical trials for new drug products as well as bioavailability/bioequivalence studies and post-marketing surveillance activities.

Who must comply with 21 CFR 312?

All sponsors and investigators who are involved in conducting clinical investigations subject to FDA jurisdiction must comply with 21 CFR 312. This includes all sponsors and investigators who submit an Investigational New Drug application (IND) to the FDA or an Abbreviated New Drug Application (ANDA).

What are the key requirements of 21 CFR 312?

The key requirements outlined in 21 CFR 312 include obtaining informed consent from study participants; providing accurate records; establishing quality assurance procedures; protecting the rights and welfare of study subjects; ensuring appropriate data collection and analyses techniques; evaluating data integrity; maintaining confidentiality of subjects and their information; training personnel involved in the trial on GCP protocols; preparing detailed reports of findings; establishing audit trails; gaining approval from an Institutional Review Board before beginning any trial activity and many more important elements.

How does 21 CFR 312 affect research ethics?

By complying with 21 CFR 312, researchers ensure that human subjects are treated ethically during clinical trials. Key ethical considerations that must be met include obtaining informed consent from study participants; protecting patient privacy; minimizing risk to patients participating in trials and ensuring proper oversight throughout the duration of the trial.

What is a sponsor's responsibility when conducting a clinical investigation covered under 21 CFR 312?

A sponsor’s responsibility under 21 CFR 312 includes developing adequate protocols for each investigation, selecting qualified investigators to ensure effective oversight, obtaining informed consent forms from all patients involved in any investigational activities, providing adequate safeguards regarding patient confidentiality, informing participants about potential risks associated with any investigational activities they may be engaged in and ensuring compliance with all applicable laws related to GCP related activities.

What role does an Institutional Review Board play when conducting a clinical investigation covered under 21CFR312?

An Institutional Review Board (IRB) has a critical role when conducting investigations subject to FDA jurisdiction as outlined in21CFR312. An IRB is responsible for reviewing protocols submitted by sponsors prior to commencing any investigational activity involving human subjects. The IRB also provides ongoing review and monitoring throughout the course of an investigation to ensure continued adherence to all applicable FDA regulations related to GCP standards outlined in 21CFR312.

What type of documentation must be maintained according to 21CFR312?

According to 21CFR312 sponsors must maintain documentation outlining the duties performed by each individual involved in any investigational activity related tot he trial including protocol development activities, informed consent process details etc.. In addition sponsors must keep thorough records detailing all data collected during each stage off the trial as well as facilitate audit trails so that investigators can easily trace back any changes made during analysis or reporting stages off thee trial process..

How often should audits take place according for 21CFR312 ?

Sponsors must perform audits at least annually according twenty one C F R three twelve The objective off these audits is two ensure compliance within applicable regulatory standards In some cases additional audits may be necessary depending on complexity off thee protocol being investigated or if unusual deviations occur during thee course off thee trial ..

When should sponsors provide reports to FDA based on their findings ?

Sponsors should provide reports too FDA based on their findings no later than thirty days after completion off thee investigation . If necessary , requesting additional time due two extenuating circumstances can bee performed before submitting report results .

Review Questions for 21 CFR 312

MCQ 1: What is the purpose of 21 CFR 312?

A. To establish rules and regulations for the production and sale of drugs

B. To protect public health by ensuring drug safety

C. To reduce the cost of pharmaceuticals

D. To create standards for food safety

Answer: B. To protect public health by ensuring drug safety. 21 CFR 312 is a section of federal regulations that are designed to ensure drug safety through the establishment of rules and regulations for their production, distribution, labeling, quality control and advertising. The primary goal of this regulation is to protect public health by guaranteeing that all pharmaceutical products meet minimum standards for efficacy, potency, purity and quality.

MCQ 2: What type of information must be included on a label in accordance with 21 CFR 312?

A.Ingredient list

B.Expiration date

C.Instructions for use

D.Nutritional value

Answer: A. Ingredient list. According to 21 CFR 312, all pharmaceutical labels must include an ingredient list containing information about all active ingredients used in the product as well as any inactive ingredients that make up more than 2% of the total weight or volume of the product. Additionally, labels must also include information about any colorants used as well as impurities present in trace amounts that could adversely affect users if consumed in large quantities over time.

MCQ 3: How often must pharmaceutical companies submit manufacturing records to the FDA?

A. Monthly

B. Annually

C. Quarterly

D. Biannually

Answer: C Quarterly. Pharmaceutical companies must submit detailed manufacturing records to the Food and Drug Administration (FDA) on a quarterly basis when filing reports required by 21 CFR 312, Subpart G-Requirements for Registration of Manufacturers/Processors/Packers/Holders (§312). This includes comprehensive records regarding quality control systems testing procedures, manufacturing facilities, operations specifications, equipment maintenance schedules and more that demonstrate compliance with FDA regulations for safe production practices and product quality assurance purposes

MCQ 4: What role does advertising play within 21 CFR 312?

A .It is permitted but heavily restricted

B .It is not mentioned at all

C .It is prohibited altogether

D .It is unrestricted

Answer : A It is permitted but heavily restricted. The advertising and promotion requirements outlined in 21 CFR 312 provide comprehensive guidance on how firms should market their products while remaining compliant with regulatory requirements set forth by the Food & Drug Administration (FDA). While these regulations do permit firms to advertise their products under certain conditions it also places several restrictions such as prohibiting false or misleading claims or engaging in deceptive practices when promoting their products

MCQ 5 : Which type of information can be shared between manufacturers when trading biological materials according to §312.50(a)(1)?

A .Confidential trade secrets

B .Patent information

C .Test results

D .Facility locations

Answer : C Test results. Section 312.50(a)(1) outlines which types of information can be shared between manufacturers when trading biological materials such as microorganisms or raw materials intended for use in animal feed or fertilizer applications, medicinal drugs or food additives etc.. Test results from safety analysis performed on such materials may be shared between manufacturers provided they have been adequately validated for accuracy prior to disclosure

MCQ 6: Which factors are taken into account when determining whether a clinical trial should be conducted?

A. The predicted risk or benefit associated with a drug's use

B. The number of participants needed in a study to obtain valid results

C. The cost associated with conducting the trial

D. All of the above

Answer: D. All of the above. 21 CFR 312 states that clinical trials must be conducted in order to determine whether a drug is safe and effective and that considerations such as potential risks, benefits, number of participants needed for valid results, and cost must all be taken into account when making this determination.

MCQ 7: When must an investigational new drug application (IND) be submitted according to 21 CFR 312?

A. When initiating any clinical investigations involving a new drug

B. When submitting new marketing applications for a drug product

C .When introducing any changes to an approved drug product

D .All of the above

Answer: A .When initiating any clinical investigations involving a new drug . According to 21 CFR 312, an IND must be submitted prior to initiating any studies or trials involving an investigational new drug or biologic agent in humans in order to ensure patient safety and health protection standards are met prior to initiation of these activities.

MCQ 8: What type of data is required when submitting an investigational new drug application (IND)? A . Clinical data from past trials involving similar products

B .Data on animal testing conducted using the proposed product

C .Data on manufacturing processes used during development

D .All of the above

Answer: D .All of the above . In order for an IND to be approved by FDA regulatory authorities all available information regarding preclinical studies, pharmacology/toxicology studies, chemistry manufacturing controls, previous clinical experience with similar products, proposed protocol(s), investigator qualifications must all be submitted alongside supporting documents outlining these details so that decisions can be made based on available data points provided in these documents.

MCQ 9: What type of review process takes place after submission of an investigational new drug application (IND)?

A . Statistical analysis using collected clinical data

B .A comprehensive evaluation by FDA regulatory experts

C .Approval from Institutional Review Board (IRB)

D .All of the above

Answer: D .All After submission of an IND both statistical analysis using collected clinical data as well as comprehensive evaluations by FDA regulatory experts take place in order for decisions about approval or rejection to be made; additionally Institutional Review Boards review all materials before approving studies or trials for conduct with human participants per FDA guidelines outlined in 21 CFR 312

CCRPS offers certification with 21 CFR 312 review in depth. Demo our courses today to learn more.

Most Common Clinical Trial Therapy Areas

Top 5 Clinical Trial Areas Shaping Healthcare in 2024

Sure! Here's the updated blog content with all the course links added in the relevant sections:

The relentless pursuit of medical progress hinges on clinical trials. These meticulously designed studies evaluate the safety and efficacy of novel treatment approaches, paving the way for breakthroughs that improve and extend lives. With the number of global clinical trials steadily rising, staying abreast of the most prominent research areas is crucial. This blog post delves into the top 5 clinical trial areas capturing attention in 2024, exploring their prevalence, funding, anticipated outcomes, and the exciting future of clinical research.

Oncology: Spearheading the Fight Against Cancer

Cancer remains a leading cause of death globally, necessitating a relentless quest for innovative therapies. In 2024, oncology continues to reign supreme in clinical trial research, accounting for nearly half of all ongoing trials worldwide. The United States stands as a leader, boasting over 25,000 active oncology trials, closely followed by Europe's collaborative efforts in cancer research.

Driven by a shared global mission, governments, pharmaceutical giants, and non-profit organizations have poured billions into cancer research. In the United States alone, the National Cancer Institute (NCI) secured over $6.5 billion in funding for 2024. This year's prominent trials target notoriously challenging cancers like lung, breast, and pancreatic cancers, with a focus on immunotherapy, targeted therapies, and cellular therapies. Advancements in technology and international collaboration promise a bright future for oncology research, pushing the boundaries of cancer treatment ever further. Those looking to manage such trials can gain valuable expertise through the Advanced Clinical Research Project Manager Certification.

National Cancer Institute

Alliance for Clinical Trials in Europe

American Cancer Society

Neurology: Battling the Burden of Neurological Disorders

Neurological disorders like Alzheimer's disease, Parkinson's disease, and multiple sclerosis cast a long shadow, impacting millions worldwide. Recognizing this growing burden, neurology has become a frontrunner in clinical trial research. The United States leads the pack, followed by Europe and Asia.

Global funding for neurological clinical trials reached new heights in 2024, with a particular emphasis on tackling neurodegenerative conditions like Alzheimer's and Parkinson's. Public and private sectors joined forces, with organizations like the National Institutes of Health (NIH) allocating over $3 billion to neurological clinical trials in 2024. These trials aim to achieve breakthroughs in slowing down, preventing, or even curing these debilitating diseases, ultimately enhancing the quality of life for affected individuals. For those looking to contribute to this field, the Clinical Trials Assistant Training can provide essential skills and knowledge, while the ICH-GCP course offers guidance on good clinical practice standards.

National Institutes of Health (.gov)

Infectious Diseases: Combating Emerging and Re-emerging Threats

The COVID-19 pandemic served as a stark reminder of the critical role research plays in combating infectious diseases. In response, the field has witnessed a surge in clinical trials specifically focused on infectious diseases. Funding for these trials has received a global boost, with both public and private sectors contributing to the development of novel vaccines and treatments.

In 2024, clinical trials in infectious diseases tackled both novel pathogens and resurging threats like tuberculosis and malaria. The World Health Organization (WHO) played a pivotal role in funding and initiating these trials, collaborating with governments and pharmaceutical companies to ensure rapid response and treatment development. These trials' outcomes will contribute significantly to global health security, ensuring preparedness for future pandemics and disease outbreaks. The Pharmacovigilance Certification course is designed for those interested in monitoring the safety of these crucial medical interventions.

World Health Organization

Cardiology: A Global Fight Against Cardiovascular Disease

Cardiovascular disease (CVD) remains a leading cause of death worldwide, claiming nearly 18 million lives annually. In 2024, cardiology clinical trials focused on improving prevention, diagnosis, and treatment of CVD, encompassing areas like heart failure, coronary artery disease, and hypertension.

Funding for cardiology research came from a multitude of sources – government agencies, non-profit organizations, and pharmaceutical companies. The United States, Europe, and several Asian countries allocated substantial resources to support these clinical trials. The anticipated outcomes emphasize personalized and precision medicine approaches in cardiovascular healthcare.

Oncology: One of the most common clinical trials by therapy area is oncology, which involves testing medications and treatments with the goal of helping to improve patient outcomes when dealing with various types of cancer. Examples of these clinical trials include those that seek to determine the efficacy of new drugs in treating particular forms of cancer, or researching novel therapeutic approaches such as immunotherapy.

Cardiovascular Disease: Clinical trials related to cardiovascular disease are also quite common. These tests may involve assessing the effectiveness of new medications that can help lower blood pressure or improve cardiac function, as well as examining lifestyle interventions such as diet and exercise for their potential to reduce risk factors associated with heart disease.

Diabetes: Clinical trials related to diabetes are also a frequent occurrence due to its prevalence in many parts of the world. These studies often aim to understand how better management strategies for diabetes can improve quality of life for patients and reduce long-term complications associated with this condition.

Neurology: Clinical trials pertaining to neurology are commonplace in research settings because there is still much unknown about how the brain and nervous system work, as well as treatment effectiveness for conditions like epilepsy, Parkinson’s disease, multiple sclerosis, and stroke recovery.

Mental Health: Mental health-related clinical trials are becoming increasingly more common as researchers continue to investigate and develop better treatments for depression, anxiety disorders, bipolar disorder, schizophrenia, PTSD, addiction and other issues related to mental health and wellbeing.

Respiratory Disease: Clinical trials involving respiratory diseases, such as asthma or chronic obstructive pulmonary disease (COPD), have become more commonplace in recent years due to their rising prevalence throughout the world; they typically involve testing new medications or therapies that can help manage symptoms and reduce exacerbations associated with these conditions.

Immunology: Immunology-focused clinical research has become more popular over recent years due to its potential implications for developing treatments for autoimmune diseases like rheumatoid arthritis or lupus; these clinical trials often involve testing existing medications or creating new ones from scratch in order to achieve desired results regarding immune system regulation within individuals living with autoimmune conditions .

Gastroenterology: Gastroenterological clinical research is commonplace due primarily to its relevance within digestive disorders such as Crohn’s Disease or Irritable Bowel Syndrome (IBS). Research conducted in this area generally seeks to gain an understanding into how certain dietary changes or drug treatments might be effective at managing symptoms associated with gastrointestinal problems while reducing side effects associated with traditional pharmacological approaches .

Endocrinology: Endocrinological clinical research is yet another form of study found in medical circles due primarily via its relevance within hormone-related issues such as diabetes mellitus type 1 & 2; this type of study typically involves testing ways in which different hormones might interact differently between individuals who have similar conditions but don't respond positively/negatively the same way when it comes to traditional forms of treatment .

Ophthalmology: Last but not least is ophthalmology which looks at vision disorders like glaucoma and age related macular degeneration (AMD); here researchers test existing medications/treatments looking for improvement when it comes both short term relief from eye pain/blurring but also long term protection against further loss/damage occurring over time via regular monitoring sessions

Learn more about clinical trials and become involved in management of clinical trials through further training with CCRPS.