STUDY NAME Site Number: ______________________ Pt_ID: ______________________ Has the participant had any Adverse Events during this study? Yes No (If yes, please list all Adverse Events below) Severity Study Intervention Action Taken Regarding Study Outcome of AE Expected Serious Relationship Intervention 1 = Yes 1 = Mild 1 = Definitely related 1 = None 1 = Resolved, No Sequel 1 = Yes 2 = No 2 = Moderate 2 = Possibly related 2 = Discontinued permanently 2 = AE still present- no treatment 2 = No 3 = Severe 3 = Discontinued temporarily 3 = AE still present-being treated 3 = Not related (If yes, 4 = Reduced Dose 4 = Residual effects present-not complete SAE 5 = Increased Dose treated form) 6 = Delayed Dose 5 = Residual effects present- treated 6 = Death 7 = Unknown Adverse Event Start Date Stop Date Severity Relationship to Action Outcome Expected? Serious Initials Study Treatment Taken of AE Adverse Event? 1. 2. 3.
STUDY NAME Site Number: Pt_ID: ______________________ ______________________ Has the participant had any Adverse Events during this study? Yes No (If yes, please list all Adverse Events below) Severity Study Intervention Relationship Action Taken Regarding Study Intervention Outcome of AE Expected Serious 1 = Mild 2 = Moderate 3 = Severe 1 = Definitely related 2 = Possibly related 3 = Not related 1 = None 2 = Discontinued permanently 3 = Discontinued temporarily 4 = Reduced Dose 5 = Increased Dose 6 = Delayed Dose 1 = Resolved, No Sequel 2 = AE still present- no treatment 3 = AE still present-being treated 4 = Residual effects present-not treated 5 = Residual effects present- treated 6 = Death 7 = Unknown 1 = Yes 2 = No 1 = Yes 2 = No (If yes, complete SAE form) Adverse Event Start Date Stop Date Severity Relationship to Study Treatment Action Taken Outcome of AE Expected? Serious Adverse Event? Initials 1. 2. 3.
Adverse-Event-Form.docx