Certified Clinical Research Coordinator (CCRC) Practice Exam

Who is legally responsible for reporting the investigator's financial interests to the FDA?

1. The investigator

2. The Institutional Review Board (IRB)

3. The sponsor

4. The funding agency

The correct answer is: The sponsor

The sponsor holds the legal responsibility for reporting the investigator's financial interests to the FDA. This is crucial because the sponsor plays a central role in ensuring that all regulatory requirements are met for a clinical trial. In situations involving potential conflicts of interest, the sponsor must ensure that any financial interests of the investigator that could affect the integrity of the research are disclosed to the FDA. While the investigator has a responsibility to disclose their financial interests to the sponsor, it is ultimately the sponsor's duty to compile this information and submit it to the FDA as part of the trial oversight and compliance process. The sponsor's actions help maintain the transparency and trustworthiness critical to the safety and efficacy of clinical research. The IRB primarily focuses on the ethical aspects of the study and participant protection, while the funding agency may provide financial support but does not take on the regulatory reporting duties. Therefore, while investigators, IRBs, and funding agencies play essential roles in clinical research, it is the sponsor who is specifically tasked with the responsibility of reporting financial interests to the FDA.