Adjustment for baseline covariates in clinical trials

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/295050/2013
Effective from01/09/2015
KeywordsBaseline covariates, stratification, dynamic allocation, multicentre trials, baseline imbalance
DescriptionThis document provides advice on how to address important baseline covariates in designing, analysing and reporting clinical trials. It mainly focuses on confirmatory randomised trials.

Document history 

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/09/2015–present


Published: 27/03/2015


Published: 28/06/2013


Published: 29/02/2012

Superseded documentPoints to considerIn operation: 01/11/2003–31/08/2015

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