The University of Tulsa: Institutional Review Board
Adverse Event/Problem Report Form
ADVERSE EVENTS/PROBLEM REPORT FORM
Principal Investigator
PI Name:
Email Address:
University Status
(Faculty, UG Student,
Grad Student, etc.):
College/ Department:
Mailing Address:
IRB Protocol Number:
Phone Number:
Current Date:
Title of Study:
Faculty Mentor/Contact (if student is PI)
Name:
Email Address:
University Status
(Faculty, Staff, etc.):
College/ Department:
Campus
Address:
Phone Number:
Indicate the type of event/problem:
(check all that apply)
Adverse event (physical or psychological harm) as determined by The University of Tulsa PI that is:
(1) unexpected (in terms of nature, severity or frequency) given the research procedures that are described
in the protocol and informed consent form?
Adverse event (physical or psychological harm) as determined by The University of Tulsa PI that is:
(2) related or possibly/likely related to participation in the research?
Adverse event (physical or psychological harm) as determined by The University of Tulsa PI that:
(3) suggests that the research places subjects or others at a greater risk of harm (physical, psychological,
economic or social) than previously known or recognized?
A complaint of a participant that indicates an unanticipated risk OR any complaint that cannot be resolved by the
research staff
Breach of confidentiality
An accidental or unintentional deviation to the IRB-approved protocol that involved risks
An emergency protocol deviation without prior IRB review to eliminate an apparent immediate hazard to a research
participant
Specific protocol-defined events that require prompt reporting to the sponsor
Information that indicates a change to the risks or potential benefits of the research. For example:
 An interim analysis or safety monitoring report indicating that frequency or magnitude of harms or
benefits may be different than initially presented to the IRB; OR
 A paper published from another study indication that the risks or potential benefits of the research may
be different than initially presented to the IRB.
Incarceration of a participant in a protocol not approved to enroll prisoners
Sponsor imposed suspension for risk
Location of event:
YES
At The University of Tulsa
Indicate campus location:
At a site listed in the IRB application
Other- Explain:
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The University of Tulsa: Institutional Review Board
Adverse Event/Problem Report Form
Continuing Participation
YES
NO
N/A
YES
NO
Is the study permanently closed to enrollment?
Is anyone still involved in the current study and receiving treatment/intervention?
Problem/Event
Date of problem/event :
Date of discovery of problem/event :
Has the same or similar problem/event occurred previously in this study?
If yes, what is the number of times this event has occurred?
Is the problem/event ongoing?
If no, date problem ended :
Briefly describe the problem/event AND indicate whether any action has been taken. (you may submit a
separate attachment):
List any potential recommendations that you propose in light of this event.: (Check all that apply)
The Informed Consent Form should be revised for new subjects
Currently enrolled and/or future participants should be notified about this problem/event
Past participants should be re-contacted and given revised information about the study
The research protocol should be revised (you may need to submit a TU Mod. Req. Form)
The research study should be suspended or terminated
The participant should discontinue the study intervention
The participant should withdraw from the study
No reconnection with the subject
Other: Specify:
Additional Comments/Recommendations:
Principal Investigator Certification: My signature certifies that all necessary information has been
reported to The University of Tulsa Institutional Review Board.
___________________________________________________
Principal Investigator’s Signature
___________________________
Date
________________________________________________
If PI is a student: NEED Faculty Mentor’s Signature
___________________________
Date
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