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

Who is responsible for sending Annual Progress Reports to the IRB/IEC?

1. The Sponsor

2. The Investigator

3. The Clinical Research Coordinator

4. The Principal Investigator

The correct answer is: The Investigator

The responsibility for sending Annual Progress Reports to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) generally lies with the Investigator. In clinical research, the Investigator is tasked with overseeing the conduct of the study and ensuring that all regulatory requirements are met, which includes the obligation to update the IRB/IEC on the study's progress. Annual Progress Reports provide essential information about the ongoing research, including data on subject recruitment, adverse events, protocol adherence, and any modifications to the study protocol. This information is critical for the IRB/IEC to ensure that the research is being conducted ethically and safely, and that the rights and welfare of participants are being protected throughout the study. While the Sponsor may play a role in the trial's overall management and funding, and the Clinical Research Coordinator may assist in data collection and management, it is ultimately the Investigator's responsibility to ensure that these reports are submitted. The Principal Investigator, if distinct from the Investigator mentioned in the choices, would also typically have the overall responsibility for submission but is not separately listed in this context. Hence, the answer indicating the Investigator aligns with the standard practices in clinical research regarding communication with the IRB/IEC.