UT Health Science Center San Antonio Issues requiring prompt reporting to the IRB Refer to the definitions and policies for guidance: General - Not specific to a protocol 1. Issue/Event: Related to a single protocol, complete below (check one) Related to multiple protocols, complete and add rows as needed 3. Protocol 2. PI Name, if Number, if HSC applicable: applicable 4. Protocol Title, if applicable: 5. 6. Email for Dept Department Chair (if other than Chair UT Outlook) 8. Person reporting 7. Date of this Report: event 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: cannot be explained by the subject’s underlying condition or predisposing UPIRSO risk factors (Unanticipated Problem Involving Risk to is unanticipated (not listed in the documentation previously submitted to the Subjects or Others) 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 nature, severity , or degree of incidence UADE life-threatening problem not previously identified in nature, severity , or (Unanticipated Adverse Device degree of incidence Experience) death unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects Check all that are applicable, any of which may also be an unanticipated Noncompliance (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 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)
UT Health Science Center San Antonio Issues requiring prompt reporting to the IRB Refer to the definitions and policies for guidance: 1. Issue/Event: (check one) General - Not specific to a protocol Related to a single protocol, complete below Related to multiple protocols, complete and add rows as needed 2. PI Name, if applicable: 3. Protocol Number, if HSC 4. Protocol Title, if applicable: 5. Department Chair 6. Email for Dept Chair (if other than UT Outlook) 7. Date of this Report: 8. Person reporting event 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): UPIRSO (Unanticipated Problem Involving Risk to Subjects or Others) ALL of the following must be true: cannot be explained by the subject’s underlying condition or predisposing risk factors 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 UADE (Unanticipated Adverse Device Experience) At least one of the following must be applicable: serious adverse effect on health or safety not previously identified in nature, severity , or degree of incidence life-threatening problem not previously identified in nature, severity , or degree of incidence death unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects Noncompliance (Failure to conduct the study as directed by the IRB approved protocol or according to applicable regulations and local policies) Check all that are applicable, any of which may also be an unanticipated problem and provide details in description: adversely affects subject safety or the safety of others increases risks to subjects violates the rights and welfare of participants Emergency Violation (Unapproved change made to the protocol to eliminate an apparent immediate hazard) Provide justification for unapproved change in description. applicable
IRB%20Issue%20Prompt%20Report.docx