Certified Clinical Research Coordinator (CCRC) Practice Exam

Who is primarily responsible for making the initial risk determination for a device being used in a clinical study?

1. The clinical trial coordinator

2. The sponsor-investigator

3. The regulatory affairs manager

4. The independent ethics committee

The correct answer is: The sponsor-investigator

The primary responsibility for making the initial risk determination for a device being used in a clinical study lies with the sponsor-investigator. The sponsor-investigator is typically the individual who oversees the study and has comprehensive knowledge of the device's clinical use, its design, and its safety profile. This person must assess the potential risks associated with the device, considering factors such as the target population, the study design, and previous data on the device's use. By evaluating these aspects, the sponsor-investigator can make informed decisions about the risks involved, which ultimately informs the regulatory submissions and ethical considerations of the study. This role is critical in ensuring that patient safety is prioritized and that the research can proceed in compliance with regulatory standards and ethical guidelines. The other roles mentioned, such as the clinical trial coordinator and regulatory affairs manager, play supportive roles in ensuring compliance and managing clinical operations but do not carry the primary responsibility for the initial risk determination. The independent ethics committee, while vital in reviewing and approving the study to ensure ethical standards, does so based on the risk assessment provided by the sponsor-investigator, rather than making the initial determination themselves.