Serious Adverse Event (SAE) Report Form
Adverse Event FormSTUDY NAMESite Name:___________________________Pt_ID:_________________________This form is cumulative and captures adverse events of a single participant throughout the study. SeverityStudy Intervention RelationshipAction TakenRegarding Study InterventionOutcome of AEExpectedSerious AdverseEvent (SAE)1 = Mild2 = Moderate3 = Severe4 = Life-Threatening0 = Not related1 = Unlikely related2 = Possibly related3 = Probably related4 = Definitely related0 = None1 = Dose modification2 = Medical Intervention3 = Hospitalization4 = Intervention discontinued5 = Other1 = Resolved2 = Recovered with minor sequelae3 = Recovered with major sequelae4 = Ongoing/Continuing treatment5 = Condition worsening6 = Death7 = Unknown1 = Yes2 = No1 = Yes2 = No(if yes, complete SAE form)At end of study only: Check this box if participant had no adverse eventsNoneAdverse EventStart DateStop DateSeverityRelationshipAction TakenOutcome of AEExpected?SAE? ................
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