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Serious Adverse Event (SAE) Tracking and Reporting Protocol Title: Protocol Number: Qualified Investigator/Principal Investigator:Participant ID:Type of report: Initial Follow up # Final1. SAE Onset
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Serious adverse event (SAE) is an incident that results in death, a life-threatening condition, inpatient hospitalization, prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Sponsors, investigators, and clinical research organizations (CROs) are required to file serious adverse event (SAE) reports.
To fill out a serious adverse event (SAE) report, one must include detailed information about the event, patient demographics, medical history, treatment received, and any relevant laboratory findings.
The purpose of serious adverse event (SAE) reporting is to ensure patient safety, monitor the effects of medical interventions, and maintain the integrity of clinical trials.
Information that must be reported on a serious adverse event (SAE) form includes the event description, onset date, severity, outcome, relationship to study drug, and any actions taken in response.
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