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

What authority does the Data and Safety Monitoring Board (DSMB) have regarding clinical trials?

1. Authorize informed consent

2. Recommend protocol changes

3. Endorse financial sponsors

4. Control participant recruitment

The correct answer is: Recommend protocol changes

The Data and Safety Monitoring Board (DSMB) plays a critical role in overseeing the safety and efficacy of clinical trials. One of its key authorities is to recommend protocol changes. This authority is essential because the DSMB is responsible for monitoring the data collected during the trial and ensuring that participant safety is prioritized. If the DSMB finds that certain aspects of the trial protocol are not safeguarding participants or if the evolving data suggest that modifications are necessary to improve the trial's design or its potential outcomes, they have the authority to suggest changes. In contrast, while informed consent is an essential part of conducting clinical trials, the DSMB does not have the authority to authorize it; this responsibility typically falls on the investigators and institutional review boards (IRBs). Endorsing financial sponsors is also outside the purview of the DSMB, which is focused on the scientific and ethical conduct of the trial. Similarly, controlling participant recruitment is typically managed by the trial investigators and their study teams rather than the DSMB, although the DSMB may evaluate recruitment strategies as part of their oversight duties.