Adverse Event Form - National Institutes of Health
STUDY NAMESite Number:Pt_ID:____________________________________________ Has the participant had any Adverse Events during this study? FORMCHECKBOX Yes FORMCHECKBOX No (If yes, please list all Adverse Events below)SeverityStudy Intervention RelationshipAction Taken Regarding Study InterventionOutcome of AEExpectedSerious1 = Mild2 = Moderate3 = Severe1 = Definitely related2 = Possibly related 3 = Not related1 = None2 = Treatment Stopped 3 = Treatment Interrupted4 = Reduced Dose5 = Increased Dose6 = Delayed Dose1 = Resolved, No Sequel2 = AE still present- no treatment3 = AE still present-being treated4 = Residual effects present-not treated5 = Residual effects present- treated6 = Death7 = Unknown1 = Yes2 = No1 = Yes2 = No(If yes, complete SAE form)Adverse EventStart DateStop DateSeverityRelationship to Study TreatmentAction TakenOutcomeof AEExpected?Serious Adverse Event?PIInitials& Date1.2.3. ................
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