Sponsor Notification of Adverse Event

1. Study Information

Protocol Title
Protocol Number
Sponsor Name
Study Site
Principal Investigator (PI)
Study Coordinator

2. Subject Information

Subject ID
Date of Birth / Age
Sex
Enrollment Date

3. Adverse Event Details

Adverse Event Term / Diagnosis
Description of Event
Severity (Mild/Mod/Sev)
Onset Date
End Date
Serious? (Y/N)
Outcome
Treatment Required
Is Event Related to Study Drug/Device?
Action Taken with Study Drug/Device

4. Reporting Information

Date Site Became Aware
Notified to Sponsor On (Date)
Notified by (Name & Title)

5. Additional Comments

Signature (PI)

Date