Statistical Principles for Clinical Trials ICH Topic E9: Guidance for industry

E9: Statistical Principles of Clinical Trials. 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.

Data and Resources

Additional Info

Field Value
Last Updated April 17, 2026, 17:57 (UTC)
Created April 17, 2026, 17:57 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2017-05-18 00:00:00
open_canada_keywords {"fr": ["principes statistiques", "essais cliniques", "ICH Topic E9", "lignes directrices pour l'industrie"], "en": ["statistical principles", "clinical trials", "ICH Topic E9", "guidance for industry"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Principes statistiques pour les essais cliniques ICH thème E9 : Ligne directrice à l'intention de l'industrie
update_frequency as_needed