Sae__.mp4

: Requires inpatient admission or prolongs an existing stay.

: 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. Sae__.mp4

: Results in a persistent or significant change to normal life functions. : Requires inpatient admission or prolongs an existing stay

An event is classified as "serious" if it meets one or more of the following criteria: : Regardless of the perceived cause. Sae__.mp4