Annual progress report to whom?

• A. Sponsor.
• B. IRB/IEC.
• C. Regulatory authority.
• D. The public.

Answer: (B)

The main idea is that ongoing ethical oversight requires the study to be reviewed at least once a year to protect participants. In ICH GCP contexts, investigators submit an annual progress report to the IRB/IEC so the committee can perform continuing review and decide whether to renew, modify, or stop the study. The report updates the IRB on how the trial is being conducted, including recruitment progress, safety findings, protocol amendments, deviations, and any changes to the informed consent form. This keeps subject protections current and ensures that the risk-benefit balance remains acceptable as the study progresses. The sponsor is responsible for oversight from a sponsor perspective and safety reporting to regulators, but the annual report for continuing ethical review belongs to the IRB/IEC. Regulatory authorities may request information for regulatory purposes, and some information may be shared publicly in certain contexts, but the routine annual progress report is directed to the IRB/IEC.