IRB Adverse Event Report
Revised December 2007
Adverse Event Reporting Form
Title of Project:
University of North Carolina Wilmington
Institutional Review Board
For IRB Use Only
Protocol #: _________________
Receipt Date: _______________
Last Approval Date:_________
Orig. Rev. Type: ___________
Protocol Number:
Funding Source (if any): OR Not funded research
Principal Investigator: Department:
PI Phone: PI Email:
Check if this is student research. Name of Student:
Adverse Event Date Report Date
1) a. Describe the adverse event or problem involving risks to subjects or others. b.
Was this event unexpected, or an expected risk of the research?
Unexpected event
Explain:
Expected risk of research c.
Was the event related or possibly related to the subject’s participation in the research?
Related or possibly related
Explain:
EXPIRATION DATE:
Unrelated
2) Does this event change the assessment of risks to subjects or others?
Yes No
Explain:
3) Describe the actions that were taken to immediately address these risks.
4) Describe the actions that are planned to minimize the risks to subjects and others. If changes to the protocol are planned (including changes to the informed consent), attach a Protocol Amendment Form.
P
V
A
L
P
P
R
O
D
A
T
E
:
#
:
A
L
R
O
P
O
S
A
P
#
:
S
A
L
O
P
O
#
:
S
A
L
P
O
R
P
R

5) Describe any withdrawal of subjects from the research or complaints about the research since the last IRB review.
6) Describe the communication you have had with the sponsor or other outside agencies regarding this event.
The information provided in this report is accurate to the best of my knowledge. I assure the IRB that my work involving human participants has been conducted in accordance with the policies and procedures of the University of North Carolina
Wilmington, and within the previously approved protocol and conditions, if any, imposed by the IRB.
____________________________________________
Principal Investigator’s Signature
(Or Responsible Individual Designated on Protocol)
Type Name
__________________
Date
Submit one original signed, hard copy and one electronic copy to Angela Pennell
Kelly in ORSSP, (hard copy to Hoggard Hall, Room 174 or Post Box 5973, electronic copy to kellya@uncw.edu
.)
7) Attachments
None
Protocol Amendment Form
Other
IRB Use ONLY:
Type of Adverse Event: Major Minor
Unanticipated Problem? Yes No
________________________________________________
Signature of the IRB Chair or Designate
__________________
Date
If major, Institutional Official notified by IRB Chair. Date:
If major, full IRB notified by RCO. Date:
If funded, funding agency notified. Date:
If unanticipated problem, OHRP notified. Date:
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