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Clara Fargo
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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
ICH GCP (E6 R3) Refresher Course Course & Certification
Intermediate
4.7
★★★★★
97% Recommended
Updated 2026
3 hours
189 active users
3 points
Your Study Basket
1 x ICH GCP (E6 R3) Refresher Course
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eBookWorth £29— Yours FREE when you purchase today.
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Each course includes:
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
Fully compliant
This course meets the required standard for basic GCP training, allowing learners to work on clinical trials. Learners also receive 6 Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
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About
The ICH GCP (E6 R3) Refresher Course is designed to help clinical research professionals understand and apply the latest updates to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guideline. The revised E6(R3) framework emphasizes participant safety, data integrity, quality by design, and risk-based approaches to clinical trial management in an evolving research environment.
This course provides a concise review of the key changes introduced in ICH E6(R3), including core GCP principles, Risk-Based Quality Management (RBQM), investigator and sponsor responsibilities, data integrity requirements, informed consent processes, ethics committee oversight, and documentation standards. Upon completion, learners will receive a certification demonstrating their understanding of ICH GCP E6(R3) requirements and their commitment to conducting high-quality, compliant clinical research.
Who Should Enrol?
- Clinical Research Associates (CRAs)
- Clinical Research Coordinators (CRCs)
- Principal Investigators and Sub-Investigators
- Clinical Trial Managers and Clinical Operations Professionals
- Regulatory Affairs and Quality Assurance Personnel
- Pharmaceutical, Biotechnology, and CRO Employees
- Life Science, Pharmacy, Nursing, and Medical Professionals
- Ethics Committee (IEC/IRB) Members
- Professionals seeking to refresh their GCP knowledge
- Anyone involved in the conduct, oversight, or management of clinical trials
What you will learn
Understand the key updates in ICH GCP (E6 R3), including its core principles, ethical requirements, participant safety, and data integrity expectations.
Learn the application of Risk-Based Quality Management (RBQM), Quality by Design (QbD), Critical-to-Quality (CtQ) factors, and proactive risk oversight throughout the trial lifecycle.
Develop knowledge of investigator, sponsor, and ethics committee responsibilities, including informed consent, safety reporting, oversight, and quality management requirements.
Gain practical understanding of data integrity, computerized systems, essential documentation, record retention, and inspection readiness to ensure regulatory compliance and reliable clinical trial outcomes.
Course Syllabus
- Purpose of the refresher, evolution of GCP, and objectives of the R3 revision
- Structural changes, overarching principles, and the move toward flexible, risk-based frameworks
- Ethical conduct, participant safety, data reliability, and Quality by Design fundamentals
- Critical to Quality factors, QTLs, and proactive risk oversight through the trial lifecycle
- Oversight in decentralized settings, delegation, consent processes, and safety reporting
- Quality Management Systems (QMS), CRO oversight, monitoring strategies, and data control
- ALCOA+ principles, validation of electronic systems, remote data handling, and archiving
- Strengthened IEC/IRB roles, continuous ethical review, and modern consent approaches
- Essential documents, version control, and secure archiving of trial records
- Recap of key changes, implementation checklist, and final knowledge quiz
- 📘 Bonus: ICH GCP (E6 R3) Refresher eBook (Free with purchase)
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Frequently Asked Questions
ICH E6(R3) introduces modernized principles reflecting today’s clinical trial landscape — including decentralized and hybrid studies, digital data collection, and proportionate quality oversight. This course highlights the key changes from R2 to R3, emphasizing Quality by Design, Risk-Based Quality Management, and the strengthened roles of investigators, sponsors, and ethics committees.
- The key updates and structure of ICH GCP E6(R3)
- How to apply Quality by Design and Critical to Quality concepts
- The fundamentals of risk-based and proportionate monitoring
- Updated expectations for data integrity and digital systems
- Enhanced ethical requirements for participant protection and informed consent
This course is designed for professionals who have previously completed full ICH GCP (E6 R2) training and now need a concise refresher on thelatest updates introduced in E6 (R3).
It’s ideal for:
- Clinical researchers, investigators, and site staff who want to stay current with evolving GCP standards
- Sponsor and CRO teams seeking a quick update on R3-specific changes
- Quality assurance, regulatory, and compliance professionals maintaining ongoing certification
- Experienced GCP learners who prefer a focused, 2-hour update rather than a full certification course.
This GCP Refresher Course is globally accepted and widely recognised by leading pharmaceutical sponsors, biotechnology companies, and Contract Research Organisations (CROs).
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