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: Requires inpatient admission or prolongs an existing stay.

This information pertains to the reporting of in clinical trials, a critical regulatory requirement for maintaining patient safety and data integrity. Core Reporting Timelines

: Results in a persistent or significant change to normal life functions. Sae__.mp4

: Investigators must generally report an SAE to the sponsor within 24 hours of becoming aware of the event.

: The participant was at immediate risk of death at the time of the event. : 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

: Required to prevent one of the outcomes listed above. Required Reporting Information SAE Reporting and the IRB: Adverse Events in Drug Studies : Investigators must generally report an SAE to

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