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

In a randomized clinical trial, who is responsible for reporting a termination of an arm due to increased risk?

1. Research coordinator

2. Principal Investigator (PI)

3. Sponsor representative

4. Clinical trial assistant

The correct answer is: Principal Investigator (PI)

The responsibility for reporting a termination of an arm in a randomized clinical trial due to increased risk primarily falls on the Principal Investigator (PI). The PI has the overall responsibility for the conduct of the trial, ensuring the safety and welfare of the participants, and adherence to the study protocol and regulatory requirements. When an arm of the trial is terminated due to safety concerns, it is crucial that the PI communicates this information to relevant parties, including the Institutional Review Board (IRB), the study sponsor, and, if applicable, the participants affected. The PI's role as the lead researcher also encompasses assessing the risk-benefit ratio of continuing the study and making informed decisions based on the data collected. Although research coordinators, sponsor representatives, and clinical trial assistants play essential roles in the execution of the study, they do not hold the ultimate responsibility for reporting significant changes related to trial safety. Their functions may involve support tasks, data management, and communication, but the authority and obligation to report such critical matters lie with the Principal Investigator.