UPIRSO FU Report 2007 V16

IRB #: HSC______UT Health Science Center San Antonio

ISSUES REQUIRING PROMPT REPORTING TO THE IRB Refer to the definitions and policies for guidance:  Noncompliance  UPIRSO definition  Protocol deviations definition definition  UADE definition  Protocol violations definition  Noncompliance Policy  Unanticipated Problems  Emergency violations definition Involving Risk to  Deviations and Violations Policy Subjects or Others Protocol exceptions definition (UPIRSO) And  Unanticipated Adverse Device Effects (UADE) Policy

 Help Determining whether an AE is an Unanticipated problem

 Help Determining whether a non_AE is an Unanticipated problem General - Not specific to a protocol 1. Issue/Event: Related to a single protocol, complete below (check one) Related to multiple protocols, complete below and add rows as needed 3. Protocol Number, if 2. PI Name, if applicable: HSC applicable: 4. Protocol Title, if applicable: 6. Email for Dept Chair (if 5. Department Chair other than UT Outlook) 8. Person reporting event 7. Date of this Report: name and phone: 9. Date PI or Person Reporting Learned of Issue/Event: 10. Date(s) of Issue/Event: 11. Institution(s) where Issue/Event occurred: 12. Department and room number, if applicable: 13. Participant number or Medwatch number (if applicable)

14. Category of Issue (check all that apply): ALL of the following must be true: UPIRSO cannot be explained by the subject’s underlying condition or predisposing (Unanticipated Problem Involving Risk to risk factors Subjects or Others) is unanticipated (not listed in the documentation previously submitted to the IRB or an increase in incidence or severity of anticipated events) is definitely or probably related to the research suggests the research places subjects or others at a greater risk of harm At least one of the following must be applicable: serious adverse effect on health or safety not previously identified in UADE nature, severity , or degree of incidence (Unanticipated Adverse Device life-threatening problem not previously identified in nature, severity , or Experience) degree of incidence death unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects Noncompliance Check all that are applicable, any of which may also be an unanticipated (Failure to conduct the study as directed problem and provide details in description: by the IRB approved protocol or adversely affects subject safety or the safety of others

v June 2016 1 IRB #: HSC______according to applicable regulations and increases risks to subjects local policies) violates the rights and welfare of participants Emergency Violation (Unapproved change made to the protocol to eliminate Provide justification for unapproved change in description. an apparent immediate hazard) Breach of confidentiality involving private, identifiable information (nonAE Ensure you have also notified the Institutional Privacy Officer UPIRSO) Enrollment of vulnerable population for which IRB approval was not in place (i.e. Provide details below. prisoner, child) Other (i.e. premature study closure due Specify in description. to a safety issue)

15. Description: Describe in detail the event or problem being reported (include cause/outcome)

16. Has this particular issue occurred before? No Yes 16a. If yes, describe previous issue/event here:

17. Action Plan: N/A Already Initiated Planned but Pending Modify protocol or study procedures (details provided below) The research will be voluntarily placed on hold, pending more information or resolution of problem The research will be voluntarily closed. Additional training of study staff will be provided (details provided below) No action is planned. (details provided below) Provide details for above items here:

Describe other actions done so far or future actions not listed above here (including Sponsor determinations and actions):

18. Prompt Reporting Requirement Type (Check one if applicable) Internal Unanticipated Adverse Device Experience (UADE) 10 days External Unanticipated Adverse Device Experience (UADE) 14 days UADE involving an unreasonable risk to subjects requiring 5 days termination by the sponsor of all investigations or parts of investigation presenting that risk

v June 2016 2 IRB #: HSC______Internal UPIRSOs 7 days External UPIRSOs 14 days Life threatening Internal UPIRSOs or fatal Internal UPIRSOs 48 hours (“fatal toxicities”) Emergency Violations 7 days Prompt Reporting Requirement met? No (Explain below) Yes If not, explain:

19. Did the event involve a subject from any of the categories of special populations? No. Yes. If yes, check the applicable vulnerable population(s) the subject(s) belongs to: Vulnerable Population Children Pregnant women/fetuses Non-viable neonates / neonates of uncertain viability Prisoners Cognitively impaired (adult surrogate consent)

v June 2016 3