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Reference: ACRP. “ICH E6(R2) to ICH E6(R3) Comparison.” (Jan 28, 2025) — terminology & essential records: PDF Clinical Trials Toolkit. “Summary of Key Changes in ICH E6(R3).” (Mar 25, 2025) — proportionality, QbD, safety reporting: Article PharmaEduCenter. “Key changes between ICH GCP E6 R3 and E6 R2.” (Aug 10, 2025) — structure & glossary: Blog CITI Program. “Navigating the Transition from ICH E6(R2) to ICH E6(R3).” (Mar 12, 2025) — consent & site practices: Blog IntuitionLabs. “ICH E6 (R3) Explained.” (Updated Jan 13, 2026) — rationale, data governance: Deep dive

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