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

What does the Data Safety and Monitoring Board (DSMB) monitor during clinical trials?

1. Financial resources of the study

2. Public interest in the study

3. Progress, safety data, and efficacy endpoints

4. Overall enrollment statistics

The correct answer is: Progress, safety data, and efficacy endpoints

The Data Safety and Monitoring Board (DSMB) is an independent group of experts that plays a critical role in overseeing the safety of participants involved in clinical trials. The primary responsibilities of the DSMB include monitoring the progress of the study, examining safety data, and evaluating the efficacy endpoints. The focus on progress involves reviewing how the clinical trial is unfolding, ensuring that it is on track to meet its objectives while adhering to the planned timelines. Safety data is crucial, as the DSMB assesses any adverse events or side effects that may arise, which is vital for protecting participants' well-being. Lastly, monitoring efficacy endpoints allows the DSMB to determine whether the treatment is demonstrating the intended benefits compared to the control or standard care, guiding decisions on whether the trial should continue, be modified, or be terminated for safety concerns. The other options do not align with the primary role of the DSMB. While overall enrollment statistics may be monitored, they are secondary to the core mission of ensuring participant safety and assessing treatment efficacy. Financial resources and public interest are outside the typical purview of the DSMB's responsibilities in a clinical research context.