Who submits the final report by the investigator to IRB/IEC and, where applicable, to regulatory authorities?

• A. Record of Retained Samples
• B. Final Report by Investigator to IRB/IEC Where Required
• C. Final Trial Close-Out Monitoring Report
• D. Audit Certificate

Answer: (B)

At study completion, the investigator has the duty to inform the ethics/IRB and, where required, regulatory authorities with a formal final report. This Final Report by Investigator to IRB/IEC Where Required is the official document that summarizes how the trial was conducted, how many subjects were enrolled and completed, data-quality and protocol adherence, and any deviations or important safety outcomes. It provides a clear closure and allows the IRB/IEC—and regulators if applicable—to review the study’s conduct and findings.

Other items relate to different aspects of trial operations: recording retained samples pertains to material storage, the final trial close-out monitoring report is typically a sponsor/monitor-focused document documenting site close-out activities, and an audit certificate is an assurance document from an audit rather than the investigator’s report to oversight bodies.