Data Safety Monitoring Committee
A Data Safety Monitoring Committee (DSMC) is a multidisciplinary group of independent external expert. They monitor the progress, safety data and, if needed critical efficacy endpoints of a clinical trial for the sponsor.
Based on its review the DSMC provides the sponsor with recommendations regarding study modification, continuation or termination. A DSMC is usually indicated for clinical trials with patients suffering from life-threatening diseases, or when the trial is performed in a pediatric population or with incapacitated subjects even in a non-critical indication.
When a Data and Safety Monitoring Committee is set up, then the composition of the committee, its working method and criteria for prematurely terminating the clinical trial should be documented in a code or charter. If so, the DSMC charter is included in section K of the reserach file that is reviewed by the reviewing committee (i.e., MREC
or CCMO).
Data Safety Monitoring Committees also go under different names like Data Monitoring Board or Data Monitoring Committee (Board).
Read the paper below and test your knowledge on the role of DSMC in the quiz.