Welcome to Version 1.0 of Interpretation and Application of ICH E6(R2) – an online course developed by the MRCT Center with a multi-stakeholder international team of experts and reviewed and endorsed by the Training Subcommittee of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

We are aware that a draft version of “ICH Harmonized Guideline Good Clinical Practice (GCP) E6(R3)” has been disseminated for public consultation. We will revise this online training after the final version of ICH E6(R3) has been disseminated. Nevertheless, the concepts, interpretation, and application of this online training are still applicable. Please contact us if you have questions.

This online training was developed in collaboration with and has been endorsed by ICH. At the end of the course, after successful completion of embedded quizzes, you will receive a certificate of completion. The recipient of GCP training is expected to retain this documentation of their training to fulfill the US National Institutes of Health (NIH) requirements for GCP training of clinical investigators and clinical trial staff (Notice NOT-OD-16-148). This online course also meets the TransCelerate GCP training minimum criteria.

This is an introductory course consisting of the following 10 modules that reflects the ICH Guideline  E6(R2): Guideline for Good Clinical Practice. The content is particularly directed at governmental regulatory reviewers and inspectors and is also applicable to other stakeholders including investigators, study teams, ethics committee members, research organizations and sponsors. This course takes approximately 5 hours to complete, while specific modules range from 20-40 minutes.

• Module 1: What is ICH E6(R2) and how does it apply to regulatory reviewers and inspectors?
• Module 2: The 13 Principles of ICH GCP
• Module 3: IRB Responsibilities
• Module 4: Investigator Qualifications and Responsibilities
• Module 5: Sponsor Responsibilities
• Module 6+7: Clinical Trial Protocol and Protocol Amendment(s) and Investigator Brochure
• Module 8: Essential Documents
• Module 9: GCP in Practice for Reviewers: Risk-based Monitoring as one element of Quality by Design
• Module 10: GCP in Practice for Inspectors
• Module 11: Key Takeaways of this Training

To access the modules, please follow these instructions:  ICH E6(R2) Enrollment Instructions.pdf

After completion of all modules with at least 80% accuracy, a certificate of completion can be obtained.

View Chinese modules, here (translations done by PATH)

For any questions, please contact: Carmen Aldinger (caldinger@bwh.harvard.edu).