Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which of the following is NOT a responsibility of the Data Safety and Monitoring Board (DSMB)?

1. Assessing trial progress

2. Monitoring safety data

3. Recommending trial commencement

4. Evaluating efficacy endpoints

The correct answer is: Recommending trial commencement

The reason why recommending trial commencement is not a responsibility of the Data Safety and Monitoring Board (DSMB) lies in the primary function of this independent board. DSMBs are typically focused on overseeing the ongoing safety of participants in clinical trials and evaluating the data collected throughout the study to ensure ethical standards are upheld. The core responsibilities of a DSMB include assessing trial progress, which involves reviewing the study’s design and participant recruitment to ensure it is being carried out as planned. They also monitor safety data, continually checking for any adverse events or safety concerns that arise during the trial. Evaluating efficacy endpoints is another crucial responsibility, as the DSMB must determine if the treatment being studied is showing promise or if it should be discontinued based on the data collected. However, the decision to commence a trial is linked to regulatory bodies and sponsors who design the study, define objectives, and ensure all necessary approvals are in place before the trial starts. Therefore, the DSMB does not play a role in recommending the commencement of a trial; its duties begin once the trial is already underway.