Data Monitoring Committees issues

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PDF iconDraft questions and answers

Deadline for comments: 31/07/2019

Reference numberEMA/492010/2018
KeywordsData Monitoring Committee (DMC); clinical trial; study design; trial integrity; early drug development phase; safety review committee; competent regulatory authority
DescriptionThe 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.

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