Interim or annual reports to regulatory authorities are typically provided by which party?

• A. Investigators
• B. Subjects
• C. Sponsor
• D. IRB

Answer: (C)

Interim or annual reports to regulatory authorities are handled by the sponsor. In clinical trials, the sponsor bears the responsibility for regulatory submissions and ongoing communications with authorities. They prepare and submit updates such as safety reports, development safety update reports, and progress updates to regulators, coordinating with investigators as needed. Investigators focus on conducting the study at their sites and reporting data to the sponsor, not directly handling regulator submissions. Subjects are participants who do not prepare these regulatory reports, and the IRB/IEC focuses on ethical oversight and continuing reviews rather than submitting regular regulatory updates.