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Protocol Amendment

Amendement / modification au protocole -- Protokoll-Amendment / Prüfplanänderung
1) A written description of a change to, or formal clarification of, a protocol.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
2) A written description of a change(s) to or formal clarification of a protocol.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.45

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