Post-Authorization Adverse Event Report Analysis Form
Please complete this form to analyze and review a post-authorization adverse event report. All fields are required for a thorough assessment. Do not enter any sensitive or personal information.
Report Reference Number
*
Date of Event
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Type of Adverse Event
*
Please Select
Serious
Non-serious
Unexpected
Expected
Other
Suspected Cause of Event
*
Please Select
Product-related
Administration error
Patient-related
Unknown
Other
Severity Assessment
*
1
2
3
4
5
Outcome of the Event
*
Please Select
Recovered
Recovering
Not recovered
Fatal
Unknown
Was the event reported to regulatory authorities?
*
Yes
No
Unknown
Assessment Table
*
Rows
Not at all
Somewhat
Moderately
Extensively
Impact on patient care
1
2
3
4
Impact on product reputation
5
6
7
8
Impact on operational workflow
9
10
11
12
Reviewer’s Overall Assessment
*
No further action required
Further investigation needed
Immediate action required
Additional Comments or Recommendations
Submit Analysis
Should be Empty: