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

What can the DSMB recommend regarding a clinical trial?

1. They can start a new trial.

2. They can recommend modifications, terminations, or continuations of the current trial.

3. They can make decisions about the trial design.

4. They solely recommend changes based on participant feedback.

The correct answer is: They can recommend modifications, terminations, or continuations of the current trial.

The Data and Safety Monitoring Board (DSMB) plays a critical role in the oversight of clinical trials, and its primary responsibility is to ensure the safety of participants and the validity of trial data. The board has the authority to recommend modifications to the trial protocol, including changes to the study design or methodology, based on its ongoing review of data. This ensures that any significant safety issues or efficacy concerns are addressed in real time. Additionally, the DSMB can recommend the termination of a trial if it finds that the risks outweigh the benefits or if the trial goals have been met earlier than anticipated. They also have the ability to recommend that a trial continue as planned if the data supports it. This ongoing monitoring and ability to provide recommendations on the trial's direction ensures participant safety and the ethical conduct of research. While the DSMB may consider participant feedback as part of its evaluation, its recommendations are based on comprehensive data analysis rather than solely on feedback. Therefore, describing their role in terms of recommending changes, terminations, or continuations of the current trial accurately reflects their function within the clinical trial framework.