What is the typical timeframe to report an SAE from awareness to sponsor?

What is the typical timeframe to report an SAE from awareness to sponsor?

• A. Within 24 hours
• B. Within 7 days
• C. Within 30 days
• D. Within 48 hours

Answer: (A)

SAEs must be reported to the sponsor within 24 hours of awareness. This rapid reporting allows immediate safety evaluation and risk assessment, so the sponsor can take prompt actions to protect participants, such as adjusting the protocol or pausing the trial if needed. The clock starts when the investigator becomes aware of the event, not when it occurred. After the sponsor receives the report, additional regulatory or ethics submissions may be required under separate timelines, but the initial report to the sponsor is within 24 hours. The other options exceed the allowed window for the initial sponsor notification and would delay critical safety information.

SAEs must be reported to the sponsor within 24 hours of awareness. This rapid reporting allows immediate safety evaluation and risk assessment, so the sponsor can take prompt actions to protect participants, such as adjusting the protocol or pausing the trial if needed. The clock starts when the investigator becomes aware of the event, not when it occurred. After the sponsor receives the report, additional regulatory or ethics submissions may be required under separate timelines, but the initial report to the sponsor is within 24 hours. The other options exceed the allowed window for the initial sponsor notification and would delay critical safety information.