Gene Therapy Adverse Event Assessment Form
Patient Information
Patient Name
Patient ID
Date of Birth
Sex
Male
Female
Other
Prefer not to say
Therapy Information
Gene Therapy Product
Administration Date
Adverse Event Details
Date of Onset
Time of Onset
Description
Severity
Mild
Moderate
Severe
Life-threatening
Outcome
Recovered
Recovering
Not Recovered
Fatal
Unknown
Relatedness to Therapy
Investigator's Assessment
Not Related
Unlikely Related
Possibly Related
Probably Related
Definitely Related
Action Taken
Describe Action Taken
Investigator Information
Investigator Name
Date