Who must notify the sponsor of serious adverse events and related reports?

• A. Originating Investigator to Sponsor
• B. IRB/IEC
• C. Sponsor to Regulatory Authority
• D. FDA

Answer: (A)

In this area, the responsibility for flagging safety concerns starts with the investigator at the site. When a serious adverse event occurs, the investigator who learns of it must report that event to the sponsor so safety oversight can begin right away. The sponsor then handles the appropriate downstream reporting to regulatory authorities and the ethics committee (IRB/IEC) as required. The investigator’s timely communication to the sponsor ensures the event is documented accurately, causality assessed, and the necessary expedited reports are prepared and sent through the proper channels. The other parties—IRBs/IEC, regulatory authorities, and the FDA—receive reports, but they are not the ones who first notify the sponsor.