Adverse Event Report
Ethics Committee Submission Template
Study Title
Protocol Number
Principal Investigator
Date of Report
Type of Report
Initial
Follow-up
Final
Participant ID
Date of Event
Description of Adverse Event
Severity
Mild
Moderate
Severe
Outcome
Recovered
Recovering
Not Recovered
Unknown
Death
Relationship to Study Drug/Procedure
Not Related
Unlikely Related
Possibly Related
Probably Related
Definitely Related
Action Taken
Follow-up Required
Yes
No
Additional Comments