Data Monitoring Committees issues - Scientific guideline
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.
Draft questions and answers on Data Monitoring Committees issues (PDF/105.13 KB)Draft: consultation closed
First published: 01/08/2018
Last updated: 01/08/2018
Consultation dates: 01/08/2018 to 31/07/2019
Overview of comments received on 'Draft Questions and answers on Data Monitoring Committees issues' (PDF/447.06 KB)
First published: 29/01/2021