Adjustment for baseline covariates in clinical trials

Current effective version

PDF iconAdopted 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/09/2015–present


Published: 27/03/2015


Published: 28/06/2013


Published: 29/02/2012

Superseded document PDF iconPoints to consider In operation: 01/11/2003–31/08/2015

Related content

How useful was this page?

Add your rating