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Articles tagged with “rwd-fitness-for-purpose”

ICH E6(R3) Annex 2: DCT, Pragmatic & RWD Crosswalk

A 2026 implementation crosswalk for ICH E6(R3) Annex 2, covering the 15 January 2027 EU date, remote consent, DHT and EHR controls, RWD fitness, and control ownership.

22 min read

9/19/2026

ich e6(r3) annex 2 decentralized clinical trials pragmatic clinical trials real world data good clinical practice digital health technologies clinical data governance eclinical architecture rwd fitness for purpose