Adverse Event / Unanticipated Problem Reporting Form
Study Title
Principal Investigator
Report Date
Event/Problem Type
Adverse Event
Unanticipated Problem
Event/Problem Description
Date of Event/Problem
Location of Event/Problem
Study Participant(s) Affected
Immediate Actions Taken
Outcome
Was the Study Temporarily Suspended?
Yes
No
Reporting to Other Agencies (if applicable)
Additional Comments
Submitted By
Signature