Process for Submitting Safety Reports
- Serious Adverse Event (SAE’s)

Adverse Events

It is the responsibility of the investigator to ensure that written notification of serious adverse events occurring in research subjects are submitted to the St. Luke’s IRB.  

An adverse event (AE) is defined as any occurrence that has unfavorable and/or unintended effects on research subjects, regardless of severity or study-relatedness. Adverse events may manifest as new findings (signs, symptoms, diagnoses, laboratory results) or alterations in pre-existing conditions.

A serious adverse event (SAE) is any adverse event that results in death; is life-threatening, results in or prolongs inpatient hospitalization, results in a persistent or significant disability, incapacity (a substantial disruption of the participant’s ability to conduct normal life functions), a congenital anomaly or birth defect or jeopardizes the participant or requires intervention to prevent one of the outcomes listed above.

Reporting requirements

Only adverse events that are serious (as defined above) must be reported to the IRB. Serious adverse events must be reported within 24-48 hours of the event or the investigator being notified of the event.