Understanding ICH E6 (R3) Good Clinical Practice and Computerised Systems

By Rephine

The ICH E6 (R3) guideline on Good Clinical Practice was published on 6 January 2025, and will be adopted by the European Medicines Agency (EMA) on 23 July 2025. While ICH E6 (R3) retains the foundational principles of ICH E6 (R2), it introduces significant updates that align with technological advancements and modern clinical trial methodologies.

This free white paper explores the key changes in ICH E6 (R3) and provides insights into the practical implications for sponsors, contract research organisations and clinical investigators, particularly regarding computerised systems validation.

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