ICH E6(R3) Annex 2 Finalised at Step 4, Expanding GCP Guidance for Modern Clinical Trials

5th June 2026

Summary: The International Council for Harmonisation (ICH) has released the final Step 4 version of ICH E6(R3) Annex 2, completing a significant update to the global Good Clinical Practice (GCP) framework. Annex 2 provides additional guidance for clinical trials that incorporate decentralised elements, pragmatic trial designs and the use of real-world data (RWD). The guideline reinforces the application of quality by design and risk-proportionate approaches while maintaining participant safety, rights and data integrity. It addresses emerging trial methodologies such as remote visits, digital health technologies, electronic health records and other external data sources, helping sponsors, investigators and regulators apply GCP principles consistently across increasingly diverse clinical research models. The document complements the overarching E6(R3) Principles and Annex 1, reflecting the continued evolution of clinical trial design and conduct.

Link: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Annex%202_Guideline_Step%204_2026_0603_0.pdf

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