How to Become a CRA in Canada: Clinical Research Associate Certification
How to Become a CRA in Canada
How to Get A Clinical Research Associate Certificate Online in Canada
CCRPS offers Canadian CRA certification for students living and working in Canada. A CRA certification in Canada provides students with additional knowledge of resources and guidelines in order to work in clinical research.
Our certification specifically state and prove that you have reviewed Canadian guidelines in clinical research and meet the competencies required for all clinical research associates.While our certificate is accredited by the ACCRE, 4 other organisations, and shows employers you have the working knowledge to act as a CRA; the CRAC credentialing exam will help further establish your professionalism. If you already have experience as a clinical research associate, you can use this course to prepare and sit for the CRAC examination.
In order to become a certified Canadian CRA, you must take the CRAC credentialing examination. To sit for the examination, you must fulfill one of these requirements:
2 years of clinical research expereience within the last 5 years
3,500 hrs of part time experience with at least 1 year of Canadian experience within the last 5 years
A post-graduate certificate in clinical research and at least 1 years’ experience over the past 2 years in clinical research. You must have at least 1 year of Canadian experience.
2. Clinical Research Associate Canada (CRAC) Membership
While CCRPS membership is free, you still benefit from obtaining CRAC membership even if you do not have enough experience to sit for the CRAC credentialing exam. Membership can create networking and job opportunities, as well as provide insight into the field. All interested professionals should become a Member of the Official Canadian CRA Association and list this involvement on their CV and cover letter.
3. CCRPS Canadian CRA Certification (CCRAC) for Resume Building
As we teach nearly 30 Canadian students each quarter, our Canadian Clinical Research Associate Certification will allow students to strengthen their application and resume, specifically towards Canadian guidelines and policies.
4. Landing A Entry Level Clinical Research Associate Job in Canada
Unfortunately, many professionals have trouble securing a job in order to get experience and take the CRAC exam. Our certification, specifically created for Canadian CRAs, provides entry-level science professionals with all the resources they need to be a working CRA in Canada. Our online exam can be taken at any time, if you enroll or demo our course.
5. Clinical Research Associate Programs in Canada
In addition to providing 130 modules, our CRA certification exam is priced affordably and the same as our American students. Students can gain valuable work experience by applying to be one of our CCRPS Clinical Research Education Fellows for a 1 month remote internship to develop and strengthen your resume.
6. Salary of Canadian Clinical Research Associate
Payscale Canadian CRA Salary
Payscale Canadian Pay Difference CRA
Clinical Research Certification Specifically for Canadian CRAs
CCRPS offers one of the only online certifications specifically designed for entry-level and mid-level professionals in clinical research associate knowledge. We prepare you to understand and apply all skills required to secure a job in clinical research.
Canadian Clinical Research Associate Certificate Course Preview
Want to Learn More About Clinical Research?
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Everything You Need to Know About Clinical Research Studies
Clinical research studies are the cornerstone of medical progress. But what exactly are they, and how can you be involved? This blog unveils the fascinating world of clinical trials, exploring how they lead to new medications, preventative measures, and improved treatments for a healthier future.
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.
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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:
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.
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.
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?
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
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
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
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
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 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.
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
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
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.
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.
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.
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.
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
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.
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.
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.
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.
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
https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/
https://www.niaid.nih.gov/research/dmid-investigational-product
Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860
https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/
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
https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra
https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/
https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/
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.
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?
Want know about the clinical research fastrack? Visit our website today and get the information about clinical research fastrack. Read more now!
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.
Introduction to Clinical Trial Training
Have you ever wondered how new medications and treatments make it from the lab to your doctor's office? The answer lies in clinical trials, meticulously designed research studies that test the safety and effectiveness of new healthcare interventions on human volunteers.
If you're curious about this fascinating field and considering a career in clinical research, an introduction to clinical trial training is a perfect first step. This blog post will equip you with the foundational knowledge to jumpstart your journey.
Why the Rise in Clinical Research Training?
The field of clinical research has seen a significant rise in demand over recent years. The evolving landscape of the pharmaceutical and biotechnology industries, with a constant push for new and improved treatments, plays a significant role in this growth.
Clinical Research Associates: The Overseeing Force
A clinical research associate (CRA) is a crucial part of the clinical trial process. They act as the eyes and ears of the sponsor, overseeing the well-being of subjects and ensuring that the study adheres to strict regulatory guidelines. They are responsible for tasks like monitoring investigator sites, ensuring data integrity, and reporting any issues or deviations from the protocol. For those interested in becoming a CRA, consider this specialized CRA training course.
Benefits of Clinical Trial Training
With the clinical research market projected for continued growth, a thorough understanding of clinical research training is essential. Here's how it benefits you:
Equipping Yourself for a Rewarding Career: This training provides the necessary skills and knowledge to launch a successful career in clinical research. There are various specializations within the field, allowing you to tailor your path to your interests.
Contributing to Medical Advancements: By participating in clinical trials, you play a vital role in developing new treatments and improving patient care. The knowledge gained through training empowers you to be a valuable asset in this endeavor.
Strong Job Market Outlook: The demand for qualified clinical research professionals is high and expected to rise further. This training positions you to take advantage of this growing market.
What Does Clinical Trial Training Entail?
Clinical trial training equips individuals with the necessary understanding of:
The Clinical Research Process: From study design and participant recruitment to data collection and analysis, you'll gain insights into the entire lifecycle of a clinical trial.
Ethical Considerations: Protecting participant safety and well-being is paramount. Training emphasizes informed consent, patient confidentiality, and responsible research conduct.
Regulatory Requirements: Clinical trials adhere to strict guidelines set forth by regulatory bodies. Training ensures you understand these regulations and can navigate them effectively.
Specific Roles and Responsibilities: The clinical research team comprises various professionals, each with distinct duties. Training clarifies your role and how it contributes to the successful execution of the trial.
Who Should Consider Clinical Trial Training?
This training is valuable for anyone interested in a career in clinical research, including:
Clinical research coordinators (Consider the Clinical Research Coordinator course)
Data managers
Clinical trial assistants (Explore the Clinical Trials Assistant Training)
Regulatory affairs specialists
Research nurses
Physicians interested in research (Check out the Advanced Principal Investigator Physician Certification)
Where to Find Clinical Trial Training
There are numerous avenues to pursue clinical trial training. Here are some options to consider:
Online Courses: Several organizations offer introductory and advanced online courses in clinical research, including Pharmacovigilance Certification and ICH-GCP.
Universities and Colleges: Many academic institutions provide certificate programs or degrees in clinical research.
Professional Associations: Industry associations often host workshops and training programs specifically designed for clinical research professionals.
Begin Your Clinical Research Journey
By taking an introduction to clinical trial training, you'll unlock a world of possibilities in healthcare advancement. You'll gain the foundational knowledge to make informed decisions about your career path in this dynamic and ever-evolving field.
Remember, this is just the beginning! As you delve deeper, you'll discover the profound impact clinical trials have on improving human health and shaping the future of medicine.
I. Clinical Research Training: Background and Importance
Before diving into the specifics of clinical research training, it's necessary to understand what clinical research is and its importance in the field of medicine. Clinical research refers to the systematic study of potential new drugs, medical devices, and techniques to establish their safety and efficacy before they can be approved for use by regulatory authorities. In simple terms, clinical research aims to ensure that new treatments and therapies are both safe and effective for human use, protecting the public from potentially harmful side effects or complications.
Clinical research, thus, plays a key role in the process of bringing novel medical treatments to market. It is a multifaceted process that requires a range of skill sets, from data analysis to ethics and compliance. Clinical research associates (CRAs) are responsible for managing clinical trials and ensuring that they adhere to relevant laws and ethical guidelines. As such, clinical research training equips potential CRAs with the necessary skills to excel in their roles and contribute to the safe development of new therapies and medical products.
II. Components of Clinical Research Training
Clinical research training typically comprises several essential components, each designed to provide a comprehensive understanding of the clinical research process. Some of the critical elements of clinical research training include the following:
1. Basic Principles of Clinical Research: An overview of the fundamentals of clinical research, including the phases of clinical trials and the importance of randomization, blinding, and placebo controls.
2. Good Clinical Practice (GCP): A thorough understanding of GCP guidelines set by regulatory authorities like the International Council for Harmonisation (ICH) and the Food and Drug Administration (FDA) to ensure the safety, integrity, and quality of clinical trials.
3. Protocol Development: Training in the design and development of clinical trial protocols, with an emphasis on creating study objectives, inclusion/exclusion criteria, and the types of assessments required.
4. Ethics in Clinical Research: In-depth exploration of ethical considerations in clinical research, including informed consent, institutional review board (IRB) approval, and data protection.
5. Regulatory Compliance: Gaining a comprehensive understanding of the role of various regulatory authorities in the clinical research process, and ensuring compliance with relevant regulations.
6. Data Management and Biostatistics: Knowledge of essential data management techniques, including data collection and validation, data quality control, and the application of biostatistics in clinical research.
7. Clinical Trial Management: Training on the roles and responsibilities of the clinical trial team and best practices in trial management, including site selection, patient recruitment, and study closeout.
8. Safety Reporting and Pharmacovigilance: An understanding of safety reporting requirements and the importance of pharmacovigilance in maintaining patient safety throughout the clinical trial.
III. Clinical Research Training: Course Options and Certifications
Numerous clinical research training programs are available for those wishing to enter or advance within the clinical research field. These programs typically cater to diverse educational backgrounds and levels of expertise, ensuring that all prospective CRAs have access to the necessary training. Courses generally range from short-duration workshops to comprehensive diploma or degree programs.
One popular and widely recognized accreditation is the Clinical Research Associate (CRA) Certification. Obtaining this certification demonstrates a commitment to excellence and professionalism in clinical research. Several organizations offer clinical research associate certification online, making it an easily accessible option for many individuals.
In conclusion, clinical research training is essential for anyone wishing to pursue a career in clinical research. It equips learners with the skills and knowledge necessary to conduct and manage clinical trials, ensuring public safety and helping to bring life-enhancing treatments to market. With various course options available, including the Clinical Research Associate Certification Online, gaining the required qualifications is more accessible than ever before.
The Clinical Trials Team - Roles & Responsibilities
In a research study, a clinical trial tests a new medical treatment or a new way of using an existing treatment to see whether it will be a better way to avoid and screen for diagnosing or treating a disease. Purpose of clinical trial:
A research study that is performed on individuals for evaluation of a medical, surgical, or behavioral intervention.
Clinical Research Careers
Clinical Research Associate (CRA)
Clinical Research Coordinator (CRC)
Drug Safety Monitor (PV)
Clinical Trial Assistant (CTA)
Clinical Research Nurse (CRN)
Medical Monitor (MM)
All Research Professionals (ICH GCP)
Types of clinical trials:
Prevention trials
Screening trials
Case control studies
Cohort studies
Cross sectional studies
Figure no. 1: clinical trial team flowchart
Clinical research trial team:
The success of a quality clinical research program is essential for developing and maintaining an impeccable clinical research trial team. It is the main component of a research program because total time and effort for conducting a clinical trial; nurses and data managers each contribute more than 30%. On the other hand, physician’s contribution to clinical research is only 9%.
Roles and Responsibilities of clinical trial personnel
Clinical research team:
Roles:
Participants are provided with information about the clinical trial.
The content of the informed consent is explained.
Reporting of adverse events or drug reactions.
report suspected misconduct.
Protect the integrity and confidentiality of records and data during the clinical study
Responsibilities:
Appropriate training
Following of GCP standard
Following required protocols
Investigator:
Roles:
• Following ethical principles.
• Provide education programs.
• Design and conduct clinical trials for policies and procedures.
• Refer to GCP course for training.
• Determines the scientific, technical, and administrative aspects of the research project.
Responsibilities:
• Conduction of trial, statement, protocol, and applicable regulations.
• Protection of rights and welfare of participants.
• Obtaining informed consent.
• Maintenance of proper records.
• Management of all safety reports and financial disclosure reports.
Figure no. 2: Roles of clinical research controller.
Figure no. 3: Responsibilities of clinical research controller.
Figure no. 6: Responsibilities of data manager.
Sponsor:
Roles:
Financial
Reputation
Legal
Responsibilities:
Selection of qualified investigators.
Ensures proper monitoring of the clinical trial.
References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3092661/ - The Clinical Research Team
https://clinicaltrialpodcast.com/clinical-research/ - 15 Clinical Research Job Roles & Responsibilities (2021)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3051859/ - Clinical Investigator Responsibilities
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042393/ - How to engage stakeholders in research: design principles to support improvement
Good Documentation in Clinical Trials
WHAT IS GOOD DOCUMENTATION IN CLINICAL TRIALS?
The medical record of the subject before, after, and during the clinical trial is a Source Document.
Characteristics of Source document:
It helps to confirm whether the individual is eligible for a clinical trial or not. For professionals looking to enhance their skills in managing clinical trials, consider the Clinical Research Coordinator course and the Clinical Trials Assistant Training course.
It documents the progress of the subject from consenting till the completion of the given clinical study.
It helps to record how much investigational product is dispensed, used, and returned by the subject.
At any point of the treatment, the source document is a complete medical record of the subject as a reference.
Finally, it forms well-built data. Then it is transcribed to CRF that translates into a clinical study report.
The source document supports the fundamental principles necessary for the protection of subjects’ rights, safety, and well-being, and aligns with the principles taught in the ICH-GCP course.
ALCOA-C:
ALCOA-C covers all the main aspects of a source document that include some crucial definitions and documentations, first introduced by the U.S. FDA.
The reason why it got implemented in medical practices; is to ensure confidentiality, credibility, accuracy, and validation. ALCOA-C is the abbreviation of some crucial terms in clinical trials that are as follow:
Figure no. 1: ALCOA-C
Attributable
Legible
Contemporaneous
Original
Accurate
Enduring
Available and accessible
Complete
Consistent
Credible
Corroborated
For those involved in pharmacovigilance, the Pharmacovigilance Certification course can provide further training on ensuring drug safety and efficacy that adheres to these standards.
Types of a Source Document:
There are two types of Source Documentation:
Electronic - Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. For more specialized training, consider the Advanced Clinical Research Project Manager Certification and the Medical Monitor Certification course.
Paper - Paper Source Documents can be handwritten data on pre-printed forms prepared in advance or handwritten records. Those aiming for leadership in clinical research might explore the Advanced Principal Investigator Physician Certification.
The most common type of Source Documentation (SD) is official medical documentation used in medical institutions regularly:
Medical History
Outpatient Medical Chart
Various Logs / Hospital Charts
For a comprehensive understanding of clinical trial documentation and monitoring, the CRA (Clinical Research Associate) course is highly recommended.
Table no. 1: examples of source document in clinical trials.
Examples of Source Document in Clinical Trial:
Participant’s medical reports
Phone encounters or notes
Report Participants diaries
Specific research worksheets
Figure no. 2: general flow chart for clinical data management.
Clinical Data Management:
The process of collecting, cleaning, and management of subject’s data following regulatory standards is known as clinical data management (CDM).
Table no. 2: tools for CDM.
Main Objectives of CDM:
To provide high-quality data.
To keep the number of errors and missing data as low as possible.
Try to get maximum data for analysis.
Table no. 3: minimum requirement for CDM team.
The electronic information obtained from the CDM must comply with the Code of Federal Regulation (CRF), 21 CRF Part 11. CRF operates the existing records in an electronic format that we created, modified, stored, archived, retrieved, or transferred. ( binny et al., 2012)
Case Report Form:
CRF is the first step in the translation of protocol-specific activities into the data being generated. It should be concise, user friendly, and self-explanatory. (binny et al., 2012)
References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121265/ - Good documentation practice in clinical research
https://conductscience.com/portfolio/alcoa-c/ - ALCOA-C
https://www.appliedclinicaltrialsonline.com/view/targeting-source-document-verification - Targeting Source Document Verification
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/ - Data management in clinical research: An overview
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/ - Basics of case report form designing in clinical research
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3857788/ - Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4386950/ - Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials
Clinical Research Associate Training UK
Clinical research is a field with a lot of career potential all over the world. Clinical research associates, or CRAs, are one of the most sought-after positions in the field. CRAs monitor labs and research processes. It is a position that offers financial security and many traveling opportunities for work. In this article, we have put together a short work guide on becoming a CRA in the UK. According to SalaryExplorer, the 2020 average salary of a CRA in the UK is 82,700 GBP. Depending on your experience and location, you can expect to earn anything from 38,000 GBP to 131,000 GBP.
United Kingdom Clinical Research Career Guide
Clinical research is a field with a lot of career potential all over the world. Clinical research associates, or CRAs, are one of the most sought-after positions in the field. CRAs monitor labs and research processes. It is a position that offers financial security and many traveling opportunities for work. In this article, we have put together a short work guide on becoming a CRA in the UK. For more detailed training, check out our CRA training program.
Salary:
According to SalaryExplorer, the 2020 average salary of a CRA in the UK is 82,700 GBP. Depending on your experience and location, you can expect to earn anything from 38,000 GBP to 131,000 GBP.
On average, CRAs with less than 2 years of experience earn an average salary of 43,200 GBP. However, a CRA’s salary increase exponentially after 2-5 years of experience, increasing by 34% (57,700 GBP per year). They increase another 48% after obtaining 5-10 years of experience (85,200 GBP per year).
Requirements to Work:
The minimum education requirement to work as a CRA in the UK is a bachelor’s degree. However, investing in a master’s degree will increase your qualifications and earning power. SalaryExplorer has shown that CRAs with a master’s degree have a 93% higher average salary than CRAs with just a bachelor’s degree. Explore our ICH-GCP course to enhance your qualifications.
Although clinical research is a global field, job requirements and salaries can differ from place to place. After reading this guide, we hope that you have a better understanding of what it is like to work in the UK. If you want to learn more about clinical research and becoming a CRA, please check out our CRA training program and our articles below to learn more about the international job scene.
The aim of this course is to help healthcare professionals and other non-medical/dental healthcare professionals and those that are already working in the clinical research industry who want to develop and acquire skills and knowledge. This course will help you to develop the knowledge of the theoretical aspects of clinical research and the skills that are relevant in research methodology that are applicable to researches in the contemporary clinical practice settings.
The benefits of taking this clinical research online course are:
It helps you to develop an in-depth knowledge and an understanding of the nature, purpose, different methods, and application of research that are relevant to clinical practice as an individual or in an organization.
It develops and builds your capacity for research and fosters evidence-based practice. This is done by equipping you with the knowledge and skills that are needed in the critical appraisal, application, designing, and undertaking of high-quality research within different range of clinical settings.
It provides you with an excellent research training with outstanding resources and expertise in the field, in a supportive environment that allows you to thrive in your pursuit for clinical research knowledge.
It will enhance your opportunity to pursue a career in clinical research and an opportunity to further your clinical research training with advanced knowledge of clinical research and practice. Consider our Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification.
It will develop your critical thinking and reflection skills, help you to be more effective in communication, improve your team and multidisciplinary work, your use of health informatics, and help you to be more systematic in decision-making and problem-solving.
You will have the opportunity to learn from and interact with renowned professionals from the clinical research field, and other health-related fields, and other industry experts who will serve as lecturers for this course.
This mode of this clinical research online program allows you to be more flexible with how you learn. The proprietor ccrps.org makes use of digital technology such as individual and group web based audiovisual tutorials and discussion boards in order to ensure the supervision of their students and constant communication. We are here to ensure that students meet the field standards and that the students are able to learn.
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
Global Pharmacovigilance Regulations
Medicine is one of the most universal forms of healthcare. However, according to the American Society of Pharmacovigilance, adverse drug events alone are responsible for $13 billion in annual American healthcare costs. The U.S Department of Health and Human Services defines adverse drug events as undesirable consequences of taking certain medications, such as “medical errors, adverse drug reactions, allergic reactions, and overdoses”. It is internationally important that a medication is professionally assessed and monitored before it is deemed safe for consumers. This is where pharmacovigilance comes into play.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse effects. PV helps determine if a drug is safe for mass consumption before it is put on the market. In addition, PV ensures that if drugs with serious adverse drug reactions are pulled from the market. The field is an integral part in clinical research. In this article, we will explore the various agencies and regulatory bodies that supervise PV as well as clinical research. For those interested in becoming a pharmacovigilance expert, Pharmacovigilance Certification is available to guide you through the essentials of drug safety.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Created in 1990, the ICH connects global regulatory bodies and pharmaceutical companies to share technical innovations and discuss guidelines. The ICH GCP, or Good Clinical Practice, is one of the global governing clinical research guidelines for the EU, America, and Japan. Understanding and staying up to date with the ICH GCP is one of the most important qualifications someone could have before entering the clinical research industry. If you have any interest in clinical research and PV, CCRPS offers a free ICH GCP course that thoroughly explains and clarifies the complex document.
The European Medicines Agency (EMA): In the European Union (EU), the EMA coordinates PV and drug safety throughout all clinical trial phases. They ensure that a drug’s effects are monitored even after they are on the market. In addition to ICH GCP, the EU uses Good Pharmacovigilance Practice (GPvP) to determine monitoring standards of drug sales.
The Food and Drug Administration (FDA): In the United States (U.S.), the FDA supervises the approval of pharmaceutical products. Specifically, the Center for Drug Evaluation and Research or CDER is responsible for handling PV. Within CDER, the Office of Surveillance and Epidemiology assembles medical officers and safety evaluators to oversee PV in their field of experience. Most officers and evaluators are medical doctors or pharmacists.
Marketed Health Products Directorate (MHPD): The Canadian Directorate assesses and regulates health product risks. They are composed of 6 different bureaus and offices, each with their own area of speciality. Together, the Directorate monitors adverse drug effects and makes regulatory decisions.
Pharmaceuticals and Medical Devices Agency (PMDA): Established in 2004, the Japanese regulatory authority PMDA supervises the safety of drugs from the lab to the market. Not only do they consult clinical trial professionals on clinical compliance, they also provide post-market safety measures and relief services for adverse health effects.
Since drug safety is important for patient health and safety around the world, there are career opportunities for PV virtually anywhere. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org. Our online Pharmacovigilance Certification guides new professionals to improve their qualifications and gain valuable insight. The course is curated by real clinical research professionals and flexible enough to fit any schedule. Moreover, for those looking to expand their career into clinical research coordination or clinical trials assistance, CCRPS offers comprehensive courses such as the Clinical Research Coordinator, Clinical Trials Assistant Training, CRA certification, Advanced Clinical Research Project Manager Certification, Advanced Principal Investigator Physician Certification, and Medical Monitor Certification.
5 Step Guide to Becoming a Successful PV Professional
Pharmacovigilance (PV), also known as drug safety, is the study of a drug’s effects. It is a specialized department within clinical research and it has a lot of potential. PV professionals record and analyze a medicine’s adverse effects before and after its clinical development. Much like clinical research, PV is a largely under-explored field with great career prospects. According to reports, the pharmacovigilance market is expected to reach $12.98 Billion worldwide by 2027. The field has opportunities for all kinds of talents, including IT and statisticians. In this article, we will break down the PV field and outline educational requirements and career tips in 5 steps.
Enroll Instantly in our Pharmacovigilance Certification with 17.5 CME Credits
Step One: Undergraduate Degrees
Most positions in PV require some level of higher education. The pharmaceutical industry is highly regulated, and employers need to be sure that you have the necessary interest and knowledge before they make a hire.
Depending on what kind of career you want in your future, an associate’s degree or bachelor’s degree can help you get there. If you are interested in clinical positions, a bachelor’s in the life sciences or health-related studies will be highly desirable. If you are interested in non-clinical positions, such as those in IT or statistics, a computer science or mathematics degree will help get you there.
During this time, look for any direct opportunities to work in clinical research. University hospitals are a great place for research assistant or patient recruiter opportunities. The PV field is hard to break into, so building relevant experiences and making connections will help you tremendously in the future. Consider enhancing your resume with a Clinical Trials Assistant Training course.
Step Two: Graduate Degrees
Graduate programs may be of interest to those who want better career opportunities or specific positions, such as a PV physician. Health professionals with degrees such as MDs, DOs, RPhs, PharmDs, RNs, LPNs, DDS/DMDs, and DVMs can easily transfer their degrees and work experience into PV positions.
On the other hand, many pursue a master’s or a PhD because they increase one’s earning potential and open up more career opportunities. If you choose to get your degree, make sure to take advantage of your school’s resources and industry connections while you still have access to them. Advanced roles may benefit from specific certifications like the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification.
Step Three: Apply for Jobs
Here comes what many consider the hardest part of a PV career: breaking into the field. PV is a competitive field, and here’s how you stay ahead:
Highlight any direct clinical research experience and get a reference from your supervisor. This will be one of the best ways to grab an employer’s interest.
If you’ve taken a graduate PV program, take advantage of your school’s resources to help with placement and networking.
Join a professional association. Network and find out how practicing professionals landed their first job. Check the association job board for positions that may not be on other job boards.
Stay up to date and informed on field practices and trends. A way to demonstrate your enthusiasm and dedication is to take advantage of online courses. For example, CCRPS offers an affordable PV certification program as well as a free ICH GCP program. Both can help add to your resume.
Before you apply, polish your resume and prepare for questions. We have an in-depth article on how to ace your interview.
Plan your career ahead. We’ve done an article on how where you work can accelerate your career trajectory and help you obtain promoted faster.
Step Four: Work and Learn
PV is an ever-growing and innovative field. When you land your first job, be prepared to transition into the workforce and learn what you were not taught in the classroom.
As you work, take in the environment around you and contemplate your long-term goals. Some factors you should consider are:
What is the work culture like?
Do you have a mentor who can guide you through this career?
Does your work environment support your professional growth?
These questions can be important when you begin to apply for senior roles, especially if you are interested in line management roles. If you find that the company goals don't align with your own, it may be worth looking for a new position somewhere else.
Most importantly, as you settle into your new job, make sure that you continue to network and re-educate yourself on the field. The effort you invest in yourself will help you stand out to the right people. Consider taking a Medical Monitor Certification to further enhance your qualifications.
Step five: Applying for Senior Positions
When PV professionals have around 5-8 years of experience, most will apply for senior positions with better pay and benefits. Although senior positions tend to be very competitive, you will be equipped with years of experience and planning. When you are applying for senior positions, here are some aspects to consider:
Your work experiences and how they fit into the position you want. Consider what sets you apart from other applicants.
Your references should not only be able tell the employer your strengths, but also your weaknesses. While this might sound counterintuitive, hiring managers know that a reference that can’t speak about your weaknesses probably doesn't know you well enough to speak about your strengths. To them, an honest reference is the sign of a strong working relationship. This will help them infer the strength in your communications skills and work ethnic.
Your skills and qualifications should not only match the job description, they should demonstrate that you are going to be a valuable member of their team.
While navigating the PV field can be complicated, the process can be immensely rewarding. If you want to learn more about the PV field, visit CCRPS for more information on our courses and check out some of our other PV articles below.
How to Land a Career in PV
According to WHO, pharmacovigilance (PV) is the science of recognizing, analyzing, and preventing a drug’s adverse effects. It is an integral part of clinical research and drug safety. In this article, we will discuss PV’s career requirements and various specializations.
Education Requirements:
To join the PV field, you will need a bachelor's or graduate degree in medicine, pharmacy, nursing, or health sciences (ex: MD, DO, RPh, PharmD, RN, LPN, DDS/DMD, DVM) . A master’s or PhD will allow candidates to specialize and enjoy more employment opportunities. Some common PV specializations are:
data management
medical safety writing
quality management
compliance management
In addition to a formal education, you will also need direct experience in collecting, organizing, processing, and analyzing PV information. The field can be very data intensive, so having a background in data management or data mining can be a huge draw for employers.
How to land a position:
If you are looking for PV positions, you’ll notice that the most common employers are pharmaceutical companies, CROs, IT firms, KPOs, PV centers, and hospitals. Some great entry level positions are:
Pharmacovigilance Specialist (average salary: $68,995 )
Record and report a drug’s adverse events after it has been on the market
Pharmacovigilance Associate (average salary: $90,557)
Ensure that clinical trials developments are following regulatory compliance.
Pharmacovigilance Scientist (average salary: $123,499)
Analyze data and compile them into reports.
Often responsible for management and leadership.
Explore Pharmacovigilance Careers: Unlock Opportunities in Drug Safety
List of Courses:
These courses are designed to enhance your qualifications and prepare you for a successful career in the dynamic field of pharmacovigilance. Whether you're starting out or looking to specialize further, explore these educational opportunities to advance your career in drug safety.
To employers, your qualification will be the number one factor that determines their hiring decision. PV is a highly technical field, and not having the skills or education you need can be disastrous for your job search. If you want to show your qualification and enthusiasm for the field, a great option would be getting PV certified. CCRPS’ online pharmacovigilance course helps new professionals improve their qualifications and gain valuable insight. The course is curated by real clinical research professionals and completely flexible to your schedule. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org.
Becoming a CRA in Canada Work Guides
Clinical research is a field with a lot of career potential all over the world. Clinical research associates, or CRAs, are one of the most sought after positions in the field. CRAs monitor lab and research processes. It is a position that offers financial security and many traveling opportunities for work. In this article, we have put together a short work guide on becoming a CRA in Canada.
Salary:
According to the Payscale, the average salary of a CRA in Canada is C$62,082. Entry level CRAs can expect to make an average of C$54,185. Late career CRAs make an average of C$107,500.
Requirements to Work:
Successful CRAs come from all kinds of backgrounds, but the minimal education requirement for a CRA in Canada is a B.A. or a B.S. with a strong focus in science. Many companies look for candidates with 1-2 years of work or monitoring experience. Since Canada’s 2 official languages are French and English, it will be important for candidates to be fluent in both languages
The Clinical Research Association of Canada (CRAC) offers a certification program for clinical research professionals to be recognized as a Clinical Research Professional of Canada (CRPC). The exam requires that you have either 2 years of clinical research experience within the last 5 years, 3,500 hrs of part time experience with at least 1 year of Canadian experience within the last 5 years, or a post-graduate certificate in clinical research and at least 1 years’ experience over the past 2 years in clinical research, where you must have at least 1 year of Canadian experience.
The certification helps already experienced professionals stand out in their fields and access better opportunities. At CCRPS, we offer a training program especially designed to help you ace the Canadian certification exam.
Launch Your Clinical Research Career in Canada: A Guide to Becoming a CRA
List of Courses:
Although clinical research is a global field, job requirements and salaries can differ from place to place. After reading this guide, we hope that you have a better understanding of what it is like to work in Canada. If you want to learn more about clinical research and becoming a CRA, please check out our website or some of our articles below to learn more about the international job scene.
How to Progress Your PV Career By Joining The Right Company
Pharmacovigilance (PV), or drug safety, is the study of a drug’s effects. Most importantly, PV monitors a drug’s adverse effects and protects consumers. PV professionals often find intellectually and financially fulfilling careers in the booming clinical research and pharmaceutical industry. Many start in the field in case management positions, but find it hard to access higher positions such as line management or technical specialists. Senior PV positions can be very competitive and difficult to acquire. However, doing research and planning ahead while you are applying for your first job can help you overcome these obstacles. Here are some tips on how to progress your career in PV.
Join the right company
When companies are hiring for senior positions, candidates must have the right qualifications and experience. However, critical experiences for higher positions can be hard to come by, especially in larger companies where case processing teams rarely work with senior level staff. When PV professionals feel that there aren't enough opportunities for growth in their work environment, one of the most effective strategies is to find and join a different kind of company. While this might seem drastic, making the change early can have lasting benefits on your career.
Here are ways your workplace shape your career:
Joining a smaller company and team will allow you to juggle more roles and gain the experience you need to apply for senior positions.
Joining a company where case processing occurs at the headquarter will allow you to work and network with more senior staff, which can prove extremely advantageous in the long run.
Joining a generics company could be the right move for you, especially if you are interested in senior technical roles. Since a generics company works with compounds that have expired patents and have been on the market for a considerable time, developing generic drugs carries less risk. Therefore, you are more likely to be promoted into signal detection work with less experience.
Joining regulatory or drug safety consultancies like CROs could also be smart for those interested in technical roles. They often offer job training for case processors to transition into signal detection roles. Additionally, since these companies specialize in outsourcing, working there would allow you to gain diverse product experiences and help your resume stand out.
Joining a health authority like the FDA or the EMA would allow you to read and analyze drug evaluations submitted by pharmaceutical companies. Your understanding on how to get approved by the regulatory bodies is a highly desirable skill set for pharmaceutical companies.
Advance Your Career in Pharmacovigilance: Navigating Opportunities in Drug Safety
List of Courses:
While applying for senior PV positions can be competitive and difficult, there are many ways for starting professionals to build their credentials while having an unique and fulfilling career. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org. We offer an online pharmacovigilance course to help new professionals improve their qualifications and gain expert insight in the field. The course is curated by real clinical research professionals and perfect for a busy schedule.
Pharmacovigilance Positions and Careers in Clinical Research
What is Pharmacovigilance?
Drugs are an integral part of healthcare. New medications are constantly developed and tested by pharmaceutical companies to be put on the market. However, according to the American Society of Pharmacovigilance, adverse drug events account for: 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care annually. Thus, it is paramount that drugs are as safe they can be.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse reactions. PV professionals work in varying specialities to ensure that a drug is safe and tested before it is consumed by the masses. In this article, we will look at the different ways PV professionals contribute to drug safety in clinical research settings.
Why is PV Important?
A drug needs to be approved by the appropriate regulatory body before going on the market. In the U.S., the FDA determines if a drug is ready for the market. Before a drug can apply for FDA approval, it must undergo three phases of clinical trials. Every proceeding phase will involve more subjects and be more risky. Thus, it is important for the clinical research team and pharmaceutical company to be sure that a drug is safe before proceeding with the next phase.
What Roles are in PV?
In clinical research, PV operations work with the clinical research team to collect information on a drug’s SAE and ADR. SAE is a serious adverse event. They can be lethal or have major repercussions such as causing disabilities in the patient or inducing birth defects. On the other hand, ADR is an adverse drug reaction. ADRs include a drug’s milder side effects, like headaches, nausea, or fatigue. The safety data collected by the operations division is key to determining a drug’s use and safety.
In addition to data collection, the operations team is responsible for creating standard operating procedures (SOPs), as well as individual case study reports, literature screening, and regulatory expedited reporting on Suspected unexpected serious adverse reactions (SUSARs), or unknown as unexpected serious adverse reactions, after the drug is on the market.
The safety data collected by the operations division is maintained by the PV systems division. They ensure that an immense amount of data is organized and accessible to research collaborators. The systems team is always working to improve and maintain safety data, since field regulations and industry expectations are always changing.
After being organized by the systems division, the safety data is then handed to the PV surveillance team. PV surveillance analyzes the safety data and then compiles their insights into development safety update reports (DSURs). This report determines whether or not the drug is safe enough to move on to the next phase of clinical trials. At the end of the third phase, if the drug is safe enough, the PV will submit the drug for FDA approval.
How Do I Start?
The PV department needs and recruits diverse talents to ensure that a drug is safe. If you can see yourself in one of these positions, then you should absolutely consider a career in PV. CCRPS recently launched our pharmacovigilance course to help aspiring professionals learn about the field and stand out in front of employers. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org.
For those who are considering further specialization within clinical research, opportunities such as becoming a Clinical Research Coordinator, CRA, or a Clinical Trials Assistant are also available. These roles are critical in the management and execution of clinical trials and offer a pathway to advanced positions like Advanced Clinical Research Project Manager Certification or an Advanced Principal Investigator Physician Certification.
For medical professionals looking to expand their expertise in overseeing clinical trial safety and compliance, our ICH-GCP course and Medical Monitor Certification provide comprehensive training in Good Clinical Practice and the responsibilities of a medical monitor in clinical research.
Top 7 Words Every Pharmacovigilance Professional Should Know
7 Key Terms You Need to Know
In the dynamic world of clinical research, ensuring medication safety throughout a drug's lifecycle is paramount. Pharmacovigilance (PV) stands as the guardian of this mission. But navigating this field requires fluency in its specific language. Here's a breakdown of 7 crucial terms every PV professional should understand in 2024, along with valuable resources to empower your journey:
1. Adverse Drug Reaction (ADR): Any unintended effect of a drug, regardless of severity or dosage. All ADRs are documented and evaluated for regulatory purposes.
Reference: Council for International Organizations of Medical Sciences (CIOMS) I Working Group III: A glossary of terms used in pharmacovigilance. Br J Clin Pharmacol. 1999;47(2):835-7. PubMed: https://pubmed.ncbi.nlm.nih.gov/10434043/
2. Side Effect: An unintended but expected consequence of a drug at the recommended dosage. Side effects differ from ADRs as they are anticipated outcomes of the medication.
Reference: Good Clinical Practice: E6(R2). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. November 2016. Available online at ICH website: https://www.ich.org/
3. Adverse Drug Event (ADE): Defined by the International Council for Harmonisation (ICH) as any unfavorable medical experience during a patient's medication use. Unlike ADRs, ADEs don't necessarily imply a causal relationship with the drug.
Reference: International Council for Harmonisation (ICH) Guidance for Industry E6(R2) Good Clinical Practice: ICH Topic E6. Available online at ICH website: https://www.ich.org/
4. Serious Adverse Event (SAE): A severe medical reaction to a drug at any dose, including life-threatening situations, hospitalization, disability, or birth defects. PV professionals assess reported events to determine if they meet SAE criteria.
Reference: ICH Topic E6(R2) Section 4.8 Definitions and Abbreviations. Available online at ICH website: https://www.ich.org/
5. Unexpected Adverse Drug Reaction (USADR): An ADR not previously documented in the drug's local labeling. If a USADR is also serious or life-threatening, it becomes a Suspected Unexpected Serious Adverse Reaction (SUSAR). These occurrences require prompt reporting to regulatory bodies by PV teams.
Reference: Regulation (EU) No 1381/2007 of the European Parliament and of the Council of 20 November 2007 on the transparency of medicinal products for human use and amending Directive 2001/83/EC, Council Regulation (EC) No 2587/95 and Directive 2004/27/EC. Europa.eu website: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32007R1381
6. Signal Detection: A cornerstone of pharmacovigilance. PV professionals leverage data analysis tools to identify trends and deviations from expected patterns in drug safety data. Signals may indicate a new, potential drug effect, either beneficial or adverse.
Reference: World Health Organization (WHO) Guidelines for Standardized MedDRA Coding and Use in Pharmacovigilance. WHO website: Although not directly related to signal detection, this is a relevant WHO resource: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
7. Causality Assessment: The process of determining the likelihood that a drug caused a reported ADE. This assessment helps PV professionals establish the level of association between the medication and the adverse event. Causality assessments can range from:
Certain: There is clear and convincing evidence that the drug caused the ADE.
Probable/likely: It is more likely than not that the drug caused the ADE.
Possible: There is a chance that the drug caused the ADE, but other factors could also be responsible.
Unlikely: It is improbable that the drug caused the ADE.
Conditional/unclassified
In addition, if you want to be more qualified in the field of clinical research, you may want to consider getting certified in several key areas. A great starting point is the CCRPS’ online pharmacovigilance course, which helps new professionals improve their qualifications and gain expert insight in the field. This course is curated by real clinical research professionals and is flexible to your schedule.
If you’re aiming to further enhance your career, CCRPS offers a variety of specialized courses tailored to different roles within clinical research. Those interested in coordinating clinical trials might consider the Clinical Research Coordinator course. For those looking to oversee clinical trial conduct, the CRA (Clinical Research Associate) course is ideal.
Aspiring clinical trials assistants who support clinical research sites can benefit from the Clinical Trials Assistant Training. If you are pursuing leadership roles in clinical research projects, the Advanced Clinical Research Project Manager Certification might be the right choice.
For physicians who wish to lead clinical studies, the Advanced Principal Investigator Physician Certification can provide the necessary expertise. Furthermore, individuals interested in ensuring the safety and efficacy of clinical trials may find the Medical Monitor Certification extremely useful.
Finally, to stay compliant with international standards in clinical research, consider our ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) course, which is crucial for anyone involved in global clinical research.
To explore these courses and learn more about how they can enhance your career in clinical research, please visit our website at CCRPS.Org.
What is Pharmacovigilance (PV)
According to the American Society of Pharmacovigilance, every year 1 million emergency department visits, 2.2 million hospital admissions, and 3.5 million physician office visits are caused by adverse drug effects. To prevent these tragedies, there is a special department in clinical research called pharmacovigilance. Pharmacovigilance, or drug safety, is the study of a drug’s adverse effects. PV professionals determine a drug’s safety and effectiveness before it is released into the market.
PV is a vast and complex discipline that requires diverse skill sets. Some roles may require administrative expertise, while others require firm understanding of statistics. Regardless, the PV department’s teams and divisions all collaborate towards one goal: to improve drug safety. Some common PV positions include:
Pharmacovigilance Specialist (average salary: $68,995 )
They record and report a drug’s adverse events after it has been on the market
Pharmacovigilance Associate (average salary: $90,557)
They ensure that clinical trials developments are following regulatory compliance.
Pharmacovigilance Scientist (average salary: $123,499)
They analyze data and compile them into reports. They are also often responsible for management and leadership.
Although there are many different positions within PV, many share common responsibilities such as:
Medical evaluation,
Assessment of expectedness and drug-ADR associations,
Casualty assessment,
Case narratives and processing,
Use of medical dictionaries,
Data mining and signal detection,
Medication error related activities
Specialized services (writing, compliance, global PV, ect)
To work in PV, you need at least a bachelor’s degree in the health sciences as well as relevant experience. Many professionals from nursing, pharmacy, and medicine find successful careers in PV. However, it is a competitive field. In PV, technical qualifications and a well rounded understanding of the human body are everything. At CCRPS, we offer a pharmacovigilance certification course that will help you better understand the industry and improve your qualifications.
Explore Career Advancements in Pharmacovigilance
Pharmacovigilance Certification
This certification will equip you with the necessary skills to effectively manage and report adverse drug reactions and ensure compliance with regulatory laws.
Clinical Research Coordinator Certification
Learn the fundamentals of clinical research coordination, enhancing your ability to manage clinical trials and patient care effectively.CRA Certification
As a Clinical Research Associate, gain expertise in monitoring clinical trials and ensuring adherence to established guidelines and regulations.ICH-GCP Certification
This certification provides thorough training in the International Conference on Harmonisation - Good Clinical Practice guidelines, crucial for anyone involved in clinical trials.Clinical Trials Assistant Training
Prepare for a role as a Clinical Trials Assistant, where you will support the administration and operational aspects of clinical trials.Advanced Clinical Research Project Manager Certification
Develop advanced skills in managing complex research projects, overseeing trial progress, and ensuring projects meet their objectives.Advanced Principal Investigator Physician Certification
This course is designed for physicians who wish to lead clinical trials, focusing on the intricacies of trial management and regulatory compliance.Medical Monitor Certification
Gain specialized skills in monitoring and overseeing the medical aspects of clinical trials, ensuring patient safety and the integrity of clinical data.
What is the Role of Pharmacovigilance in Clinical Research
What is Pharmacovigilance?
Drugs are an integral part of healthcare. New medications are constantly developed and tested by pharmaceutical companies to be put on the market. However, according to the American Society of Pharmacovigilance, adverse drug events annually account for: 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care costs. Thus, it is paramount that these drugs are as safe they can be.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse reactions. PV professionals work in varying specialties to ensure that a drug is safe and tested before it can be consumed by the masses.
Why is PV Important?
A drug needs to be approved by the appropriate regulatory body before going on the market. In the U.S., the FDA determines what drugs are ready for the market. Before a drug can apply for FDA approval, it must undergo three phases of clinical trials. Every proceeding phase involves more people and more risk. Thus, it is important for the clinical research team and pharmaceutical company to be sure that a drug is safe before proceeding with the next phase.
What Roles are in PV?
In clinical research, PV operations work with the clinical research team to collect information on a drug’s SAE and ADR. SAE is a serious adverse event. They can be lethal or cause disabilities in the patient or induce birth defects. On the other hand, ADR is an adverse drug reaction, which is a milder adverse reaction to a drug. They include conditions like headaches, nausea, or fatigue.
In addition to data collection, operations are responsible for creating standard operating procedures (SOPs), as well as individual case study reports, literature screening, and regulatory expedited reporting on Suspected unexpected serious adverse reactions (SUSARs), or unknown as unexpected serious adverse reactions, after the drugs are on the market. Those interested in a deeper dive into standard operating procedures and case studies might consider exploring the ICH-GCP course.
The safety data collected by the operations division is maintained by those in the PV systems. They ensure that the data is organized and accessible to research collaborators. The systems team is always working to improve and maintain the vast data, since field regulations and expectations are always changing.
The safety data is then handed to the PV surveillance team. PV surveillance analyzes the safety data and then compiles their analysis into development safety update reports (DSURs). This report determines whether or not the drug is safe enough to move on to the next phase of clinical research. At the end of the third phase, if the drug is safe enough, the PV will submit the drug for FDA approval. Professionals aiming to oversee such critical roles in drug safety might be interested in the Advanced Clinical Research Project Manager Certification.
How Do I Start?
The PV department needs and recruits diverse talents to ensure that a drug is safe. If you can see yourself in one of these positions, then you should absolutely consider a career in PV. CCRPS recently launched our pharmacovigilance course to help aspiring professionals learn about the field and stand out in front of employers. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org and chec.
Take courses from CCRPS and learn more on how to become a clinical research professional.
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