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

 

Current effective version

Questions and answers on Data Monitoring Committees issues

Adopted Reference Number: EMA/CHMP/470185/2020 Summary:

The aim of this question-and-answer (Q&A) document is to supplement the 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.

Document history

Draft questions and answers on Data Monitoring Committees issues

Draft: consultation closed Consultation dates: 01/08/2018 to 31/07/2019 Reference Number: EMA/492010/2018 Summary:

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.

Overview of comments received on 'Draft Questions and answers on Data Monitoring Committees issues'

Reference Number: EMA/548893/2020