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