Post-study events refer to serious adverse events that occurred after completion of a clinical study. In such cases, who is typically responsible for reporting to the sponsor?

• A. Investigator
• B. Regulatory Authority
• C. Ethics Committee
• D. Study Participant

Answer: (A)

Post-study safety reporting still rests with the investigator. If a serious adverse event occurs after a participant has completed the study but is related to the investigation, the investigator is responsible for reporting that event to the sponsor as soon as possible. The sponsor then uses that information to fulfill regulatory and ethics obligations, such as notifying authorities and ethics committees. The regulatory authority and Ethics Committee do not report to the sponsor; they receive reports from the sponsor. The study participant itself typically reports events to the investigator, not directly to the sponsor.