: Requires inpatient admission or prolongs an existing stay.
: Any new or updated information regarding an existing SAE must also be provided promptly, typically within 24 hours of the investigator obtaining the new details. Criteria for an SAE Sae__.mp4
: Sponsors have specific windows for notifying regulatory bodies like the FDA, often ranging from 7 to 15 calendar days depending on the event's severity and whether it was unexpected. : Requires inpatient admission or prolongs an existing stay