SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
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
4.7
★★★★★
97% Recommended
Updated 2025
2 hours
150 active users
2 points
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1 x ICH GCP (E6 R3) Refresher Course
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About
The ICH GCP (E6 R3) Refresher Course by Whitehall Training provides a concise yet comprehensive update on the latest revisions to the International Council for Harmonisation (ICH) Good Clinical Practice guidelines.
Designed for professionals who have already completed GCP training, this 2-hour refresher focuses on the new E6(R3) principles. It highlights the key regulatory, ethical, and operational updates introduced in the R3 revision — focusing on participant protection, digital data management, and risk-based quality systems. — helping you stay compliant, confident, and current in today’s evolving clinical research environment.
PLEASE NOTE: while this course is fully aligned with TransCelerate BioPharma Inc. training standards, Whitehall Training cannot independently verify compliance if your previous GCP certification was obtained through another provider.
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
Our GCP Certified Customers
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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).
