CAPACITY BUILDING
Resources

Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline

Training Material

Released in: October 2025

Designed and developed by: The MRCT Center, an International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) training partner

Good Clinical Practice (GCP) is an international, ethical, scientific, and quality standard for the conduct of trials that involve human participants. The MRCT Center developed and designed this course in collaboration with the ICH E6(R3) Expert Working Group (EWG). This course consists of 5 modules introducing and explaining the key concepts of the E6(R3) guideline. This training is intended for anyone involved in the conduct of an interventional clinical trial. The course links will take the learner to the ICH Training Library website. Courses are free for all registrants.

Currently available is:

Module 1: Introduction and Foundational Concepts, published in October 2025

Over the next few months, the following modules will be released as they become available:

Module 2: Responsibilities and Oversight

Module 3: Data Governance

Module 4: Informed Consent

Module 5: Essential Records