Good Clinical Practice Online Course Syllabus
An Introduction to Clinical Research
An Overview of ICH GCP
FREE PREVIEWCode of Federal Regulations
CFR 21 Part 11
Live Review Webinar - See discussion for next meeting time
Sponsor/CRO Responsibilities
13 Principles, IRB, & Investigator Roles
Informed Consent
Safety of Human Subjects in Clinical Research
Reporting Responsibilities of the Investigators
Adverse Events
Ethics of Research Involving Children
Ethics of Research Involving Mentally Incapacitated
Ethics of Research Involving Pregnant Women and Fetuses
FREE PREVIEWEthics of Research Involving Prisoners
Trial Management – Data Handling and Record Retention
Common Terminology Used In Clinical Research
Commonly Used Abbreviations and Terms in Clinical Research
Meet Your Advanced ICH GCP Certification Instructor
Cliff Dominy, PhD
ICH GCP Certification Graduate Case Studies 2024
"I appreciate how the course was structured—very interactive and engaging from start to finish." - Justin Scott Brathwaite
Justin described the ICH GCP course as comprehensive, cost-effective, and pivotal to his career. Its focus on site perspectives and key topics like ICH guidelines and SIV helped him advance to Senior Startup Specialist and transition into project management, boosting his confidence and understanding of clinical research roles.
"This course did a great job going in depth with examples and valuable information." - Aastha Shah
Aastha praised the course's well-paced, thorough structure and supportive online community. She appreciated the detailed focus on ethical research and vulnerable populations, which boosted her confidence in discussing ethical standards. The ICH/GCP certification improved her LinkedIn visibility and prepared her for career advancement, making this course a top recommendation for professionals.
"This course helped me get my job in regulatory affairs at a clinical research site." - Scott Boyle
Scott credited the course for securing his regulatory affairs role at UPenn, highlighting the essential GCP elements and detailed regulatory requirements as key. The GCP certification boosted his resume and LinkedIn visibility, opening job opportunities. The Code of Federal Regulations section directly applied to his work, enhancing his confidence and skills in the field.
"Thanks to this course, I feel more competent and confident in my role." - Stephanie
Stephanie praised the course for its comprehensive ICH GCP content and effective video format, which simplified complex topics. The end-of-video exercises were key in applying knowledge to real-world scenarios. The course boosted her confidence in job interviews and helped her secure a research assistant role, with the informed consent section significantly enhancing her professional skills.
ICH GCP Training
Good Clinical Practice Certification
I really enjoyed this training. The content was relayed in a comprehensible manner, making it "easy" to absorb the information. I highly recommend this train...
Read MoreI really enjoyed this training. The content was relayed in a comprehensible manner, making it "easy" to absorb the information. I highly recommend this training to anyone in (or transitioning into) the clinical research industry.
Read LessThe ICH GCP course reinforced my understanding on the APVASC. The material was clearly presented
The ICH GCP course reinforced my understanding on the APVASC. The material was clearly presented
Read LessGood points
Good points
Read LessIt is good course, summarises most of important GCP points and more
It is good course, summarises most of important GCP points and more
Read LessInformative session
Informative session
Read LessWhat are the benefits of the ICH-GCP certificate
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use is a regulatory compliance certificate necessary for companies involved in conducting clinical trials. The ICH-GCP is an internationally accepted standard covering the manufacture and trials of approved drugs. ICH-GCP certification involves completing a specific training course to demonstrate knowledge and understanding of Good Clinical Practice principles. After completion, participants receive a GCP training certificate indicating their awareness and understanding of ICH-GCP requirements. This certificate is proof of due diligence as required by any clinical trial subject or government regulatory agencies. The ICH-GCP certificate equips you to conduct ethical clinical studies while protecting the rights and safety of human subjects. Obtaining ICH-GCP certification is the industry standard and is necessary to prove commitment to compliance and quality assurance, such as for those looking to participate in drug development activities or secure funding from research bodies.
Good clinical practice certification
Obtaining ICH GCP certification offers numerous benefits for individuals and organizations involved in the clinical research industry. Some of the key advantages include:
Enhanced Knowledge and Understanding: ICH GCP certification provides a thorough understanding of Good Clinical Practice principles and guidelines, ensuring that professionals are well-versed in the ethical and scientific standards required for conducting clinical trials.
Improved Skills and Confidence: The certification process equips professionals with the skills and confidence needed to conduct clinical trials effectively, ensuring compliance with regulatory requirements and industry standards.
Increased Job Prospects and Career Advancement: With ICH GCP certification, professionals can enhance their job prospects and open up new career opportunities in the clinical research industry. Employers value certified individuals for their commitment to quality and compliance.
Compliance with Regulatory Requirements: ICH GCP certification ensures that professionals are knowledgeable about regulatory requirements, helping organizations avoid costly compliance issues and ensuring the safety and well-being of trial participants.
Enhanced Reputation and Credibility: Certified professionals and organizations gain a reputation for adhering to high standards of Good Clinical Practice, which can lead to increased trust and credibility within the industry.
Access to a Wide Range of Benefits: Organizations with a GCP certified workforce can experience cost savings, fewer errors in clinical trials, better patient care, improved regulatory compliance, and increased clinical trial performance.
Completion of a GCP Training Course: Enroll in a GCP training course that meets the minimum criteria for Good Clinical Practice training. These courses provide comprehensive coverage of GCP principles and guidelines.
Passing a Certification Exam: After completing the training, pass a certification exam that tests your knowledge and understanding of GCP principles and guidelines. This exam ensures that you are well-prepared to conduct clinical trials in compliance with industry standards.
Maintaining Certification: To keep your certification current, engage in ongoing education and training. This may include attending workshops, completing additional courses, and staying informed about the latest developments in the field.
Renewal of Certification: Certification programs typically require renewal every 2-3 years. This process may involve passing a renewal exam and fulfilling any additional requirements set by the certification program.
It’s essential to choose a certification program accredited by a recognized accrediting body, such as the Accreditation Council For Clinical Research & Education, to ensure the highest standards of quality and relevance.
Our Good Clinical Practice (GCP) Training Course is recognized by leading organizations in the clinical research industry. The course is compliant with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline (ICH E6 R2) and meets the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel as defined by TransCelerate. Our course is also accredited by the Accreditation Council For Clinical Research & Education. This recognition ensures that our training meets the highest standards of quality and relevance, providing you with the knowledge and skills needed to excel in the clinical research industry.
Choosing the right GCP training course is crucial for professionals in the clinical research industry. Our training program is designed to provide comprehensive training on Good Clinical Practice principles. Our course is designed to provide comprehensive training on Good Clinical Practice principles, including the responsibilities and expectations of sponsors, investigators, and other professionals involved in clinical trials. We offer a range of courses to suit different needs, including a GCP Refresher Course for those who need to update their knowledge and skills. Whether you are new to the field or looking to refresh your expertise, our courses are tailored to help you achieve your career goals in clinicalresearch.
Good Clinical Practice (GCP) training is essential for social and behavioral researchers who conduct clinical trials. Our GCP training course covers the principles of GCP and their application to behavioral intervention and social science research studies. The course is designed to provide researchers with the knowledge and skills they need to ensure that their studies are conducted in accordance with GCP principles and regulations. By completing our GCP training, social and behavioral researchers can ensure the ethical and compliant conduct of their studies, safeguarding the rights and well-being of their participants.
We offer a range of pricing options and packages to suit different needs and budgets. Our course prices include access to our comprehensive study guide, a personalized GCP training certificate, and ongoing support from our team of experts. We also offer discounts for bulk purchases and package deals that include additional training and support services. Contact us to learn more about our course pricing and packages. Investing in our GCP training ensures you receive high-quality education and support, helping you advance your career in the clinical research industry.
How to become ICH GCP Certified - Good Clinical Practice Certification
To become certified, you must complete either GCP course training or Clinical Research Training Online, which can give you valuable knowledge about relevant ICH GCP regulations and standards. Achieving success towards becoming an ICH GCP certified professional has never been easier or more possible than ever before!
Becoming ICH GCP certified can open up new possibilities in furthering your career!
After training, you will receive your Good Clinical Practice Certificate or GCP Certificates that require annual renewal. During this time, it's important to keep up with continuing education through CCRPS or CITI GCP Training so that your training remains current.
Make sure to read up on all the details regarding GCP certification training and ICH GCP training requirements
All of these tools are available online and free, making the process of gaining certification easy to access by anyone interested in taking the first step towards becoming ICH GPC Certified. Or utilizing opportunities like free online ICH GP training certificates. With all these components combined together, achieving success towards becoming an ICH GPC certified professional has never been easier or more possible than ever before!
ICH GCP certification is essential for career advancement and professional development in the clinical research industry. Certified professionals can expect to:
Enhance Job Prospects and Career Opportunities: ICH GCP certification is highly valued by employers, making certified professionals more competitive in the job market and opening up new career opportunities.
Increase Earning Potential: Certified professionals often command higher salaries due to their specialized knowledge and commitment to Good Clinical Practice.
Gain Recognition and Respect: Achieving ICH GCP certification demonstrates a commitment to excellence and adherence to industry standards, earning respect and recognition from peers and employers.
Stay Up-to-Date with Industry Developments: Certification requires ongoing education and training, ensuring that professionals stay current with the latest advancements and best practices in the field.
Demonstrate Commitment to Good Clinical Practice and Patient Safety: Certification signifies a dedication to conducting ethical and compliant clinical trials, prioritizing the safety and well-being of trial participants.
Certified professionals can also pursue specialized roles, such as clinical research coordinator, clinical research associate, or trial manager, and can work in various settings, including pharmaceutical companies, contract research organizations, hospitals, and research centers.
To maintain ICH GCP certification, professionals must complete ongoing education and training requirements. This typically involves:
Completing a GCP Refresher Course: Every 2-3 years, professionals should complete a GCP refresher course to reinforce their knowledge of Good Clinical Practice principles and stay updated on any changes in regulations and guidelines.
Participating in Continuing Education Programs and Workshops: Engaging in continuing education programs and attending industry workshops helps professionals stay informed about the latest developments and best practices in clinical research.
Staying Up-to-Date with Industry Developments: Keeping abreast of new advancements, technologies, and regulatory changes in the clinical research industry is crucial for maintaining certification and ensuring compliance.
Adhering to Industry Guidelines and Regulations: Certified professionals must continue to adhere to Good Clinical Practice guidelines and regulatory requirements to maintain their certification and ensure the ethical conduct of clinical trials.
Renewal of certification typically involves passing a certification exam and completing any additional requirements set by the certification program.
Having a GCP certified workforce is invaluable in clinical research. GCP stands for Good Clinical Practice, and it's the standard by which clinical studies must abide to ensure safety and compliance.
This can include extensive clinical research training online, as well as taking a course or passing an exam to earn one of the many GCP certificates available. CROs or Sponsors that employ staff with ICH GCP certification have access to a wide range of benefits including cost savings, fewer errors in clinical trials, better patient care, improved regulatory compliance, and increased clinical trial performance. CROs will have access to well-trained staff who are knowledgeable about good clinical practice standards which makes learning new protocols much easier and quicker. Having an ICH GCP certified workforce is essential in providing safe and ethical clinical research that meets regulatory requirements. It leads to lower failure rates and costs due to proper practices.
What is ICH GCP certification?
ICH GCP certification is a credential that demonstrates you have met the set of global standards for the ethical conduct of clinical trials. It is recognised across the globe and is a requirement for working in the clinical trial industry.
How do I become ICH GCP certified?
To become ICH GCP certified, you must pass an examination that tests your knowledge of the global standards for the ethical conduct of clinical trials. The examination is administered by a number of accredited organisations, and courses to prepare for the exam are available from many training providers.
How long does it take to become ICH GCP certified?
It typically takes a few days to become ICH GCP certified, depending on your level of experience and learning speed. However, you can begin working in the clinical trial industry before you have received your certification, as long as you can prove that you meet the requirements.
What are the ICH GCP certification standards
The International Conference on Harmonisation (ICH) has developed a number of global standards for the ethical conduct of clinical trials, collectively known as Good Clinical Practice (GCP). These standards provide guidance on all aspects of clinical trial conduct, from study design to data analysis and reporting. They are recognised across the globe and form the basis for national and regional regulations governing clinical research.
What are the ICH GCP certification standards
The International Conference on Harmonisation (ICH) has developed a number of global standards for the ethical conduct of clinical trials, collectively known as Good Clinical Practice (GCP). These standards provide guidance on all aspects of clinical trial conduct, from study design to data analysis and reporting. They are recognised across the globe and form the basis for national and regional regulations governing clinical research.
What are the benefits of ICH GCP certification?
There are many benefits of ICH GCP certification, including: - Global recognition - Increased employability - Higher earning potential - Improved knowledge and understanding of clinical trials regulations
What is the ICH GCP training course?
The ICH GCP training course is a comprehensive course that covers all aspects of the global standards for the ethical conduct of clinical trials. After you pass our ICH GCP certification course you are equipped with the knowledge and skills needed to work in the clinical trial industry.
What are the ICH GCP certification requirements?
There are a number of requirements for obtaining ICH GCP certification, including: - Be at least 18 years old - Possess a high school diploma or equivalent - Have at least two years of relevant work experience OR complete an accredited training programme
What is the ICH GCP certification process?
The process for obtaining ICH GCP certification includes: Registering for an examination with an accredited organization like CCRPS Completing an accredited training programme Passing an examination that tests your knowledge of global standards for the ethical conduct of clinical trials
A learner can choose an GCCP course suitable for the research they are preparing.
The GCP curriculum is varied by the number of modules contained. The modules contain detailed material and images, additional resources (e.g. case studies) and quizzes. The learners can finish the module individually. Each module takes approximately 30-45 minutes to complete, which is about three to six hours to get GCCP training completed.
This course will reinforce basic knowledge of basic principles of GCP. The CCRPS program recommends that learners complete basic GCP training at an appropriate time.
Yes. The module for CCRPS was updated in December 2024 and is based on ISO 1415:2020. Specifically, the GCP course for clinical trials of drugs in the laboratory and the GCP device refresher also offer specific materials from ISO 14155.
International Conference on Technical Requirement Harmonization.
ICH GCP certification is a credential that demonstrates proficiency in the International Council for Harmonisation's Good Clinical Practice guidelines. This certification is crucial for professionals involved in conducting clinical trials, ensuring adherence to ethical standards and regulatory requirements.
In GCP, ICH stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It is an organization that establishes global standards for the ethical and scientific quality of clinical trials.
GCP, or Good Clinical Practice, is a set of internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials. ICH GCP refers specifically to the guidelines developed by the International Council for Harmonisation, which are widely recognized and adopted globally.
A GCP certificate is an official document awarded upon successful completion of a GCP training course. It signifies that the holder has the knowledge and understanding of Good Clinical Practice principles and is qualified to conduct clinical trials in compliance with international standards.
ICH GCP certification is a critical component of the clinical research industry, ensuring that professionals have the knowledge, skills, and confidence to conduct clinical trials safely and effectively. By obtaining certification, professionals can enhance their career prospects, increase their earning potential, and demonstrate their commitment to Good Clinical Practice and patient safety. With the benefits of certification, including compliance with regulatory requirements, enhanced reputation, and access to a wide range of benefits, it’s essential for professionals to pursue ICH GCP certification and maintain it through ongoing education and training.
The course is effectively designed to be easily understood by the candidates, even the certification examination is designed to be easily accessed.
The course is effectively designed to be easily understood by the candidates, even the certification examination is designed to be easily accessed.
Read LessVery comprehensive and enlightening, definitely recommend to professionals
Very comprehensive and enlightening, definitely recommend to professionals
Read LessLoved the course as a whole.
Loved the course as a whole.
Read Lessgreat information on requirements and references
great information on requirements and references
Read Less
Meet Your Instructor, Former Graduate, Scientist, MCAT Tutor CCRPS
Cliff Dominy, PhD