What is the recommended timing for reporting SAEs to the sponsor per GCP?

• A. Within 24 hours of awareness
• B. Within 7 days
• C. At the next monitoring visit
• D. Only at study end

Answer: (A)

SAEs require rapid safety communication so that immediate evaluation and protective actions can be taken. The standard practice is to report an SAE to the sponsor within 24 hours of becoming aware of the event. This quick reporting enables the sponsor to assess whether the event is related to the study intervention, determine if expedited reporting to regulators or ethics committees is needed, and implement any necessary safety measures across the trial. Waiting longer—such as within 7 days, at the next monitoring visit, or only at study end—could delay crucial safety decisions and compromise participant protection. In routine practice, document the SAE and send a detailed report to the sponsor as soon as possible, but no later than 24 hours after awareness, including key information like the event date, outcome, severity, suspected relatedness to the study drug, and actions taken.