TU-IRB-Adverse-Events-problems-Form-v9.25.15

ADVERSE EVENTS/PROBLEM REPORT FORMPrincipal Investigator University Status Faculty, UG Student, Grad Student, etc.: Faculty Mentor/Contact if student is PI University Status Faculty,

ADVERSE EVENTS/PROBLEM REPORT FORM

Principal Investigator

University Status

(Faculty, UG Student,

Grad Student, etc.):

Faculty Mentor/Contact (if student is PI)

University Status

(Faculty, Staff, etc.):      

Campus

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

At The University of Tulsa

Indicate campus location:

At a site listed in the IRB application

Other- Explain:

Is the study permanently closed to enrollment?

Is anyone still involved in the current study and receiving treatment/intervention?

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.

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Principal Investigator’s Signature Date

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If PI is a student: NEED Faculty Mentor’s Signature Date