Other HIPAA authorization form. HIPAA authorization language included in the research consent form. does the site investigator or any other Key Personnel who To your knowledge and according to your institution’s policies, will participate in Human Subjects Research as part of this study have a Conflict of Interest related to the study? No Yes Please provide the name(s) of those with a Conflict of Interest and their role(s) in the study, and attach a copy of your Conflict of Interest management plan: Have all of your institution’s ancillary reviews occurred and has the site otherwise received approval to proceed with IRB review (e.g., radiation safety committee, scientific review committee, etc.)? Yes → Please list ancillary reviews and approval dates: No → Please explain: CHECKLIST: Order of attachments. (Check all that apply.) Site Investigator Qualifications 7.1 Site investigator’s current CV or biosketch Yes Per Question 2.1 7.2 Site investigator’s current medical license (copy) Per Question 2.1 Yes 7.3 Documentation of site investigator’s current Human Subjects Protection training. Per Question 2.2 Yes 7.4 Documentation of site investigator’s current Good Clinical Practice training. Per Question 2.2 Yes General Site Information 7.5 Multi-Center Supplement (0323) Yes Per Question 1.2 7.6 IRB Reliance Agreement Yes Per Question 1.3 Participant Recruitment 7.7 Letters of approach/recruitment, flyers/advertisements, recruitment phone scripts, Per Question 3.2 text of radio ads, etc. Yes If yes, please list each item below in sequential order: 7.8 International Research Performance Site Assessment Supplement (054) Yes Per Question 3.5.a 7.9 Prisoner Certification Checklist for Investigator (060) Yes Per Question 3.8.e 7.10 Children Supplement (0320) Yes Per Question 3.8.f Consenting and Compensating Research Participants 7.11 Waiver of Consent Supplement (0202) Yes Per Question 4.1 7.12 HIPAA Supplement and Waiver of Authorization (0208) Yes Per Question 4.1 7.13 Post Consent Questionnaire Yes Per Question 4.5 Documenting Consent
Other HIPAA authorization form. HIPAA authorization language included in the research consent form. To your knowledge and according to your institution’s policies, does the site investigator or any other Key Personnel who will participate in Human Subjects Research as part of this study have a Conflict of Interest related to the study? No Yes Please provide the name(s) of those with a Conflict of Interest and their role(s) in the study, and attach a copy of your Conflict of Interest management plan: Have all of your institution’s ancillary reviews occurred and has the site otherwise received approval to proceed with IRB review (e.g., radiation safety committee, scientific review committee, etc.)? Yes → Please list ancillary reviews and approval dates: No → Please explain: CHECKLIST: Order of attachments. (Check all that apply.) Site Investigator Qualifications 7.1 Site investigator’s current CV or biosketch Per Question 2.1 Yes 7.2 Site investigator’s current medical license (copy) Per Question 2.1 Yes 7.3 Documentation of site investigator’s current Human Subjects Protection training. Per Question 2.2 Yes 7.4 Documentation of site investigator’s current Good Clinical Practice training. Per Question 2.2 Yes General Site Information 7.5 Multi-Center Supplement (0323) Per Question 1.2 Yes 7.6 IRB Reliance Agreement Per Question 1.3 Yes Participant Recruitment 7.7 Letters of approach/recruitment, flyers/advertisements, recruitment phone scripts, text of radio ads, etc. If yes, please list each item below in sequential order: Per Question 3.2 Yes 7.8 International Research Performance Site Assessment Supplement (054) Per Question 3.5.a Yes 7.9 Prisoner Certification Checklist for Investigator (060) Per Question 3.8.e Yes 7.10 Children Supplement (0320) Per Question 3.8.f Yes Consenting and Compensating Research Participants 7.11 Waiver of Consent Supplement (0202) Per Question 4.1 Yes 7.12 HIPAA Supplement and Waiver of Authorization (0208) Per Question 4.1 Yes 7.13 Post Consent Questionnaire Per Question 4.5 Yes Documenting Consent