Questions and Answers Document - Structure and Content of Clinical Study Reports - ICH Topic E3(R1)

In order to facilitate the implementation of the E3 Guideline, the International Conference on Harmonisation (ICH) Experts have developed a series of Questions and Answers.

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Last Updated April 17, 2026, 17:37 (UTC)
Created April 17, 2026, 17:37 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2020-12-09 00:00:00
open_canada_keywords {"fr": ["Document de questions et réponses", "rapports d'études cliniques", "sujet ICH E3(R1)"], "en": ["Q&A Document", "clinical study reports", "ICH Topic E3(R1)"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Document foire aux questions - Structure et contenu des rapports d'étude clinique - ICH thème E3(R1)
update_frequency as_needed