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

In a multi-arm randomized clinical trial, who is responsible for providing a written report to the IRB/IEC if one arm of the protocol is terminated?

1. The site investigator

2. The sponsor

3. The principal investigator (PI)

4. The clinical research associate (CRA)

The correct answer is: The principal investigator (PI)

In a multi-arm randomized clinical trial, the principal investigator (PI) holds significant responsibilities, one of which includes maintaining oversight of the study conducted at their site. If one arm of the trial protocol is terminated, the PI is responsible for communicating this change to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). This is essential for ensuring that ethical standards are upheld and that participants are adequately informed about any changes that may affect their participation and welfare. The PI provides detailed information regarding the reasons for the termination, any potential risks to remaining participants, and plans for safeguarding their safety and rights during the transition of the trial. This ensures transparency and adherence to regulatory requirements. While the site investigator may be involved in the day-to-day aspects of the trial and the sponsor oversees the overall conduct of the study, it is the PI who is primarily accountable for the ethical conduct and reporting requirements specific to their site.