| Appendix IV: Sample Informed Consent Forms | 2006-Mar-13 | 159.82 KB |
| Manual |
| Overview and Version Control | 2006-Oct-11 | 8.08 KB |
| Section 01: Introduction | 2006-Jun-01 | 114.36 KB |
| Section 02: Protocol | 2006-Jun-01 | 52.62 KB |
| Section 03: Documentation Requirements | 2006-Jun-01 | 217.08 KB |
| Section 04: Participant Accrual | 2006-Jun-01 | 729.13 KB |
| Section 05: Informed Consent | 2006-Jun-01 | 162.57 KB |
| Section 06: Participant Follow-up | 2006-Jun-01 | 458.63 KB |
| Section 07: Visit Checklists | 2006-Jun-01 | 64.65 KB |
| Section 08: Participant Retention | 2006-Jun-01 | 104.39 KB |
| Section 09: Study Gel Considerations for Non-Pharmacy Staff | 2006-Jun-01 | 220.74 KB |
| Section 10: Clinical Considerations | 2006-Aug-30 | 240.3 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2006-Jun-22 | 177.28 KB |
| Section 12: Laboratory Considerations | 2006-Oct-09 | 481.3 KB |
| Section 13: Data Collection | 2006-Jun-27 | 1.35 MB |
| Section 14: Data Communiques | 2006-Jun-28 | 10.01 KB |
| Section 15: Study Reporting Plan | 2006-Jun-28 | 33.11 KB |