| Document |
Format |
| 1. Protocol Summary for New and Continuing Protocols |
 |
| 2. Consent Document |
 |
| 3. Drug Information Sheet |
 |
| 4. Assurances |
 |
5. Annual Adverse Event Form  |
 |
| 6. Annual Enrollment Form |
 |
| 7. Request for Waiver of Informed Consent |
 |
| 8. Request for Waiver of Signed Consent |
 |
| 9. Certification of Assent of Minor |
 |
10. Internal Adverse Event/Unanticipated Problem Report Form  |
 |
10.1 Report of Death on a Protocol  |
 |
| 11. Acknowledgement of Receipt Form |
 |
| 12. HIV Testing Consent Form |
 |
| 13. HIV Spanish Consent Form |
 |
| 14. IRB Spanish Consent Authorization Pages |
 |
| 15. Retrospective Clinical Data Study |
 |
| 16 Retrospective Research Data Study |
 |
| 17. HIV Data Review Form |
 |
| 18. Retrospective Clinical Specimen Study |
 |
| 19. Retrospective Research Specimen Study |
 |
| 20. Device Form |
 |
| 21. Humanitarian Use Device Only Form |
 |