ICH E8(R1): General Considerations for Clinical Studies

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

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Dernière modification avril 17, 2026, 21:20 (TU)
Créé le avril 17, 2026, 21:20 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2017-05-18 00:00:00
open_canada_keywords {"fr": ["ICH E8(R1)", "considérations générales", "études cliniques", "groupe de travail d'experts ICH", "consultation", "organismes de réglementation", "Assemblée ICH"], "en": ["ICH E8(R1)", "general considerations", "clinical studies", "ICH Expert Working-Group", "consultation", "regulatory parties", "ICH Assembly"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr ICH E8(R1) : Considérations générales relatives aux études cliniques
update_frequency as_needed