Upon completion of the trial, what should the investigator do?

• A. Do nothing.
• B. Inform the institution; provide the IRB/IEC with a summary of the trial's outcome, and the regulatory authority with any required reports.
• C. Publish the final report in a journal.
• D. Only inform the sponsor.

Answer: (B)

When a trial ends, the investigator has a responsibility to close out the study with the appropriate oversight and regulatory bodies. The investigator should notify the institution and provide the IRB/IEC with a concise summary of the trial’s outcomes, including what happened to the participants and the overall results, so the ethical review board can finalize its records. At the same time, the investigator must submit any required reports to the regulatory authority, following local regulations and the trial protocol, to ensure proper regulatory closure and post-trial safety oversight. This combination of informing the IRB/IEC and providing the necessary regulatory reports keeps all governing bodies informed and maintains compliance with GCP.

Publishing a final journal report, while common, is not a mandatory regulatory requirement. Informing only the sponsor omits essential oversight bodies, and taking no action fails to meet ethical and regulatory obligations for trial closure.