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.
Table of contents Background
Question 1. Are DMC recommendations binding for a Sponsor?
Question 2. Can a DMC stop a study?
Question 3. Can a DMC change study design aspects (e.g. increase sample size, drop treatment arms)?
Question 4. Is a direct communication and exchange of information between competent regulatory authorities and a DMC possible
Question 5. Is a direct communication between ethics committees and a DMC possible?
Question 6. Should trial investigators be informed about the outcome of DMC meetings
Question 7. When shall competent regulatory authorities be notified of DMC meeting outcomes?
Question 8. How should the DMC proceed when contemplating the recommendation to stop the trial?
Question 9. When is there a need for a DMC in early development phases?
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