When should a sponsor report serious adverse events (SAEs) to regulatory authorities?

The appropriate timeline for a sponsor to report serious adverse events (SAEs) to regulatory authorities is within 15 calendar days. This timeframe is mandated to ensure that regulatory bodies are promptly informed about events that could have significant implications for participant safety or the integrity of the clinical trial.

Submitting SAEs in a timely manner allows for necessary evaluations and potential responses that can mitigate risks to other participants and inform future study conduct. Consistent adherence to the 15-day reporting requirement helps maintain regulatory oversight and facilitates appropriate risk management actions. This period balances the need for timely reporting with the practicalities of gathering complete and accurate information about the event.

While other timelines, such as 10 or 30 days, may apply to different contexts or specific conditions, the 15-day window represents the standard expectation in clinical trial regulations for serious adverse events. Immediate reporting may be necessary in exceptionally critical situations, but generally, 15 days is the requisite period for most situations involving SAEs.