: A birth defect resulting from exposure to the study product.
: Requires inpatient admission or prolongs an existing stay. Sae__.mp4
This information pertains to the reporting of in clinical trials, a critical regulatory requirement for maintaining patient safety and data integrity. Core Reporting Timelines : A birth defect resulting from exposure to
: The participant was at immediate risk of death at the time of the event. Sae__.mp4
: Required to prevent one of the outcomes listed above. Required Reporting Information SAE Reporting and the IRB: Adverse Events in Drug Studies