Who is responsible for submitting the final report by the investigator to IRB/IEC and to regulatory authorities where required?

• A. Sponsor
• B. Regulatory Authority
• C. Study Participants
• D. Investigator

Answer: (D)

In ICH-GCP, the investigator is responsible for closing out the trial at the site and reporting to oversight bodies. This includes submitting the final results and relevant safety and conduct information to the IRB/IEC and to regulatory authorities as required. The investigator is best placed to provide a complete, site-specific summary of how the study was conducted, the outcomes, any deviations, and all adverse events, ensuring that the ethics committee and regulators have a clear, accurate closure record. The sponsor may handle overall regulatory submissions and provide necessary data, but the formal final report to the IRB/IEC and to regulators is the investigator’s duty, since they oversee the day-to-day conduct and safety at the study site. Participants themselves do not bear this reporting responsibility.