ICH publishes Online Training Materials for ICH E6(R3) Good Clinical Practice

The International Council for Harmonisation (ICH) has expanded its training library with new training materials for the ICH E6(R3) Good Clinical Practice (GCP) guideline. Several modules are now available to help users put the revised GCP principles into practice.

ICH regularly publishes new training offerings for its harmonised guidelines. Previously, training materials for various ICH Quality Guidelines have been made available, which we have reported on. The offerings range from introductory presentations to comprehensive, modular training packages with videos and transcripts.

The materials are developed either by the ICH expert groups responsible for the respective guideline or by dedicated implementation working groups. In addition, ICH involves so-called Training Associates, typically non-profit academic institutions with particular expertise in the respective guideline topics.

With the ongoing expansion of the ICH Training Library, ICH aims to promote the globally harmonised implementation of its guidelines.

Available training modules for ICH E6(R3)

The following training modules are currently available for the ICH E6(R3) guideline:

Module 1: Introduction and Basic Concepts - published in October 2025

• Module 1.1: Overview
• Module 1.2: Principles of ICH GCP
• Module 1.3: Basic Concepts

Module 3: Data Governance - published in October 2026

Module 4: Information and Informed Consent - published in January 2026

Module 5: Essential Records - published in September 2026

Another training offering is already in preparation: Module 2: Responsibilities and Oversight

The training materials are intended to provide structured access to the requirements of ICH E6(R3) and, in particular, to promote understanding of the core principles, responsibilities and processes in the field of Good Clinical Practice. The available content can be accessed in the Training Library for the ICH E6(R3) Good Clinical Practice Guideline.