Study Information
Study Title
Protocol Number
Site ID
Patient Information
Patient ID
Date of Birth
Age
Gender
Male
Female
Other
Adverse Event Details
Adverse Event Term
Onset Date
End Date
Description
Severity
Mild
Moderate
Severe
Relationship to Study Drug
Not Related
Unlikely
Possible
Probable
Definite
Serious Adverse Event?
No
Yes
Outcome & Actions
Outcome
Recovered
Recovering
Not Recovered
Resolved with Sequelae
Fatal
Action Taken
None
Dose Reduced
Drug Interrupted
Drug Withdrawn
Concomitant Medication Given
Other
Concomitant Medications
Reporter
Name
Role
Date