Qualitycompliance.research.utah.edu
#Adverse Event TypeOnset Date(mm/dd/yy)End Date(mm/dd/yy)AE IntensityRelationship to Study DrugAction TakenConMed/CM# (if applicable)SAETreatmentOutcomeInvestigatorReview FORMCHECKBOX Ongoing1 2 34 51 2 3 41 2 3 4 FORMCHECKBOX Yes FORMCHECKBOX No(if Yes, report SAE)1 2 3 41 2 34 5 6Date:____ _____Investigator Initial/DateSignature: FORMCHECKBOX Ongoing1 2 34 51 2 3 41 2 3 4 FORMCHECKBOX Yes FORMCHECKBOX No(if Yes, report SAE)1 2 3 41 2 34 5 6Date:____ _____Investigator Initial/DateSignature: FORMCHECKBOX Ongoing1 2 34 51 2 3 41 2 3 4 FORMCHECKBOX Yes FORMCHECKBOX No(if Yes, report SAE)1 2 3 41 2 34 5 6Date:____ _____Investigator Initial/DateSignature:AE IntensityRelationship to Study DrugAction TakenTreatment for EventOutcome1= Mild1= Not Related1= Not Applicable1= None1= Resolved2= Moderate2= Probably Not Related2= Dose Not Changed2= Medicine Taken2= Resolved w/ Sequelae3= Severe3= Possibly Related3= Drug Interrupted 3= Non-drug Therapy3= Ongoing4= Life threatening4= Probably Related4= Drug Withdrawn4= Other Medication Dose4= Death5= Death Modified5= Ongoing at Death6= UnknownPI Signature at conclusion of study participation:PI Signature:Date: ................
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