Upon completion, what should be provided to the IRB/IEC?

• A. A full patient-level data set
• B. A summary of the trial's outcome
• C. Only the sponsor's internal report
• D. No communication required

Answer: (B)

When a study ends, the ethics oversight body expects a formal final report that clearly communicates what happened and what was found. The investigator should provide a concise summary of the trial’s outcomes, including whether the study objectives were met, the overall results, and any safety or adverse event considerations. This final report helps the IRB/IEC assess the risk-benefit balance and determine if further oversight is needed.

Providing the full patient-level data set is not typically given to the IRB and raises confidentiality and data-use concerns. An internal sponsor report alone doesn’t satisfy the IRB’s need for an independent, end-of-study communication that documents outcomes and safety. Not communicating at all would leave the board without essential closure information, which is not compliant with GCP expectations.