During an IND trial, which two groups must receive Serious, suspected adverse events (SAEs) within specified timelines?

• A. Investigators and Sponsors only
• B. IRB and FDA
• C. Sponsor/IRB and FDA
• D. Patients and Sponsors

Answer: (C)

SAE reporting in an IND trial follows a defined chain to protect participants and ensure oversight. When an investigator identifies a serious, suspected adverse event, they report it promptly to the sponsor. The sponsor then has two key duties: promptly inform the ethics/independent oversight body (the IRB) and report the SAE to the FDA within the regulatory timeline. This arrangement makes the groups that must receive SAE information within specified timelines the sponsor along with the IRB, and the FDA (through the sponsor’s report). Patients themselves are not the recipients of these regulatory notifications; their role is to report events they experience to the investigator. The system ensures both internal oversight (IRB) and federal safety oversight (FDA) are alerted within the required timeframes.