| Document |
Format |
1. Protocol Summary for New and Continuing Protocols  |
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2A. ENGLISH Combined Consent / HIPAA Authorization Form Template  |
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2A. SPANISH Combined Consent / HIPAA Authorization Form Template  |
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2B. ENGLISH Standalone Consent Form Template  |
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2B. SPANISH Standalone Consent Form Template  |
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2C. Consent Documentation pages for subjects unable to read the document  |
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2D. Consent Documentation pages for subjects unable to sign the document  |
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2E. NO SIGN English Combined Consent / HIPAA Authorization Form Template  |
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3. Drug/Biologic Information Sheet  |
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| 4. Assurances |
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5. Annual Adverse Event Form  |
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| 6. Annual Enrollment Form |
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| 7. Request for Waiver of Informed Consent |
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| 8. Request for Waiver of Signed Consent |
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| 9. Certification of Assent of Minor |
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10A Internal Adverse Event/Unanticipated Problem Report Form  |
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10B Report of Death on a Protocol  |
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| 11. Acknowledgement of Receipt Form |
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| 12. HIV Testing Consent Form |
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| 13. HIV Spanish Consent Form |
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| 14. To Be Announced |
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| 15. Retrospective Clinical Data Study (if this is sole research activity, use INFOED instead) |
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| 16 Retrospective Research Data Study (if this is sole research activity, use INFOED instead) |
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| 17. HIV Data Review Form |
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| 18. Retrospective Clinical Specimen Study (if this is sole research activity, use INFOED instead) |
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| 19. Retrospective Research Specimen Study (if this is sole research activity, use INFOED instead) |
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| 20. Device Form |
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| 21. Humanitarian Use Device Only Form |
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22. Data and Safety Monitoring Plan Form  |
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23. Emergency Use Form (Unapproved Drugs/Biologics)  |
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24. Emergency Use Form (Unapproved Devices)  |
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25. Emergency Use Consent Form Template  |
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26. Engagement in Research Form (Component Research)  |
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