Interpretation and Application of ICH E6(R2)
Welcome to Interpretation and Application of ICH E6(R2) – an online course commissioned by the Training Subcommittee of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and developed by the MRCT Center with a multi-stakeholder international team of experts.
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.
- 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 our courses, please click “Courses” on the left navigation bar. (Other links above are related to our collaborator, not to MRCT Center.)
After completion of all modules with at least 80% accuracy, a certificate of completion can be obtained.
For any questions, please contact: Carmen Aldinger (email@example.com).
The primary learning objective of this activity is to learn key concepts of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) E6(R2) Guideline.
Multi-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard, & Partners HealthCare System