Draft questions and answers on Data Monitoring Committees issues

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Download document Draft questions and answers on Data Monitoring Committees issues
Reference number EMA/492010/2018
Status draft: consultation open
First published 2018-08-01
Last updated 2018-08-01
Consultation start date 2018-08-01
Consultation end date 2019-07-31
Email address for submissions biostatistics@ema.europa.eu

Summary

The aim of this question-and-answer document is to supplement the CHMP Data Monitoring Committee Guideline (Doc Ref. EMEA/CHMP/EWP/5872/03) by providing clarification on the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle as well as with regard to the responsibilities for implementing DMC decisions.