The Challenge of Managing a Data and Safety Monitoring Board

The first step is to identify the DSMB members and verify their expertise and independence. Once the experts are recruited, the Committee Charter can be finalized, and the kick-off meeting can take place. At each subsequent meeting of the DSMB, blinded and sometimes unblinded data is presented that will allow the experts to detect potential safety signals and decide on the continuation of the study. The sponsor is required to act accordingly and document all actions.