Clinical Trial SAE Reporting Template
Patient & Study Information
Subject ID
Age
Gender
Female
Male
Other
Study Name
Protocol Number
SAE Details
Date of Event Onset
Date Reported
Description of Event
Seriousness Criteria
Death
Life Threatening
Requires Hospitalization
Disability
Congenital Anomaly
Important Medical Event
Outcome
Recovered/Resolved
Recovering/Resolving
Not Recovered/Not Resolved
Fatal
Unknown
Causality Assessment
Relationship to Study Drug/Intervention
Not Related
Unlikely
Possible
Probable
Definite
Action Taken with Study Drug
None
Dose Reduced
Temporarily Discontinued
Permanently Discontinued
Concomitant Medications and Other Relevant History
Reporter Information
Reporter Name
Role/Title
Date of Report