Questions and Answers on Data Monitoring Committees Issues

On 8 October 2020 the EMA published the Q&A document on DMC issues.

The aim of this question-and-answer (Q&A) document is to supplement the Committee for Medicinal Products for Human Use (CHMP) Guideline on Data Monitoring Committee (EMEA/CHMP/EWP/5872/03 Corr) by providing clarification on (i) the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle, and (ii) the responsibilities for implementing DMC decisions. This Q&A document should be read in conjunction with this guideline using the same definitions and considerations contained therein.

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /