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.

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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