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

The University of Tulsa: Institutional Review Board Adverse Event/Problem Report Form ADVERSE EVENTS/PROBLEM REPORT FORM Principal Investigator PI Name:       University Status (Faculty, UG Student, Grad Student, etc.): College/ Department:       IRB Protocol Number:       Title of Study:             Email Address:       Mailing Address:       Phone Number:       Current Date:       Faculty Mentor/Contact (if student is PI) Name: University Status (Faculty, Staff, etc.): College/ Department:       Email Address:             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 V9.25.15 The University of Tulsa: Institutional Review Board Adverse Event/Problem Report Form Other- Explain: 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 V9.25.15 The University of Tulsa: Institutional Review Board Adverse Event/Problem Report Form V9.25.15