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

When initiating a study for a new combination of drugs, what committee is typically established for oversight?

1. Research Ethics Committee

2. Independent Data Monitoring Committee

3. Institutional Review Board

4. Safety Monitoring Board

The correct answer is: Independent Data Monitoring Committee

The establishment of an Independent Data Monitoring Committee (IDMC) is essential in overseeing studies involving new combinations of drugs, particularly when safety and efficacy concerns arise during clinical trials. The primary role of the IDMC is to assess accumulating data and ensure the trial is conducted ethically and safely. They monitor interim results to make decisions about the continuation, modification, or termination of the trial based on safety and efficacy. This oversight becomes vital when handling new drug combinations, as the safety profile can be unpredictable, and the committee has the authority to safeguard participant welfare and ensure the integrity of the study. While other committees like the Institutional Review Board (IRB) and Research Ethics Committee are important for ethical oversight and approving study protocols, the IDMC is specifically focused on real-time data analysis throughout the trial, which is crucial for drug combination studies where adverse effects or unexpected outcomes may be more pronounced. The Safety Monitoring Board operates similarly to an IDMC, but the specific distinction here leans towards the independent oversight role of the IDMC in the context of drug combination studies.