ICH guideline E17 on general principles for planning and design of multi-regional clinical trials

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/ICH/453276/2016
Effective from14/06/2018
KeywordsMRCT , multiregional, clinical trials, confirmatory trials, exploratory trials
DescriptionThe purpose of this document is to outline general principles for the planning and design of multiregional clinical trials with the aim of increasing their acceptability in global regulatory submissions. The document addresses some strategic programme issues as well as aspects specific to the planning and design of confirmatory MRCTs and should be used together with other ICH efficacy guidelines, including E2, E3, E4, E5, E6, E8, E9, E10 and E18.

Document history

First version

Current version

Adopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

Published: 18/12/2017
In operation: 14/06/2018-present

Published: 13/02/2017

Published: 28/07/2016

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