ICH E6 is the harmonized GCP guideline adopted by FDA, EMA, PMDA, and other regulators. The R3 revision (in effect 2025) emphasizes proportionate, risk-based quality management, fit-for-purpose documentation, and modern trial designs including decentralized elements.
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Glossary Term
ICH-GCP E6(R3)
Regulatory
Also known as: ICH E6, ICH GCP, ICH E6(R3), ICH-GCP
The International Council for Harmonisation's Good Clinical Practice guideline, the global standard for ethical and scientific quality in clinical trials.
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