Data Monitoring Committees issues - Scientific guideline
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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.
Keywords: Data Monitoring Committee (DMC); clinical trial; study design; trial integrity; early drug development phase; safety review committee; competent regulatory authority
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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
EMA/492010/2018 -
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Overview of comments received on 'Draft Questions and answers on Data Monitoring Committees issues' (PDF/447.06 KB)
First published: 29/01/2021
EMA/548893/2020
