ICH Good Clinical Practice E6(R3) Training material (EMA)

This resource offers a single access point to authoritative training modules, transcripts and workshop outputs explaining the aims, structure and key changes of ICH E6(R3). It helps investigator sponsors understand how the guideline encourages proportionate, flexible application of GCP across a wide range of trial designs and data sources, including studies using newer technologies and real world data. The free, structured e learning content and detailed multi stakeholder workshop report can be used to underpin institutional training, protocol development and change management activities.

Scope and Main Content

• Overview of the modernisation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline on Good Clinical Practice, including its broader focus on diverse trial types, data sources and technological innovation.
• Explanation that the ICH E6(R3) principles and Annex 1 constitute a comprehensive rewrite and reorganisation of the earlier guideline, updating international standards for clinical trials involving human participants.
• Confirmation that the revised guideline applies in the European Union from 23 July 2025, with a link to the step 5 ICH E6(R3) Guideline for Good Clinical Practice on the European Medicines Agency website.
• Links to interactive training materials hosted on the ICH website, notably Module 1 (Introduction and foundational concepts) and Module 4 (Informed consent), each accompanied by a transcript.
• Access to the Accelerating Clinical Trials in the EU (ACT EU) multi stakeholder workshop report on ICH E6(R3) principles and Annex 1, summarising key messages and perspectives from patients, healthcare professionals, regulators, ethics committee members, industry and academia.
• Information on the public consultation on draft ICH E6(R3) Annex 2 that concluded on 28 February 2025, covering Good Clinical Practice considerations for clinical trials with decentralised elements, pragmatic features and real world data, designed to be read alongside the principles and Annex 1.
• Brief news section referencing the ACT EU 2025–2026 workplan and confirming publication of the revised ICH guideline on Good Clinical Practice (principles and Annex 1).