ICH E9 statistical principles for clinical trials

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCPMP/ICH/363/96
Effective from01/09/1998
KeywordsStatistical methodology, clinical trial design
DescriptionThis document provides guidance on the design, conduct, analysis and evaluation of clinical trials of an investigational product in the context of its overall clinical development. It also assists with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.

Document history

Revision 1

In progress

Draft addendum


Overview of comments

Published: 31/08/2017


Published: 26/04/2018


First version

Current version

Adopted guideline

Published: 01/09/1998


In operation: 01/09/1998-present


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