| Study-Specific Procedures Manual (SSP) Sections |
| Overview and Version Control | 2009-Nov-04 | 87.44 KB |
| Table of Contents | 2009-Sep-09 | 96.76 KB |
| Section 01: Introduction | 2009-Aug-06 | 84.26 KB |
| Section 02: Protocol | 2009-Aug-30 | 1.02 MB |
| Section 03: Documentation Requirements | 2009-Aug-06 | 156.49 KB |
| Section 04: Participant Accrual | 2009-Aug-06 | 269.29 KB |
| Section 05: Informed Consent | 2009-Aug-06 | 281.03 KB |
| Section 06: Participant Follow-up | 2009-Aug-06 | 284.39 KB |
| Section 07: Visit Checklists | 2009-Aug-06 | 1.45 MB |
| Section 08: Participant Retention | 2009-Aug-06 | 109.35 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff | 2009-Sep-08 | 180.87 KB |
| Section 10: Clinical Considerations | 2009-Sep-08 | 475.65 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2009-Nov-03 | 608.93 KB |
| Section 12: Counseling Considerations | 2009-Aug-06 | 434.32 KB |
| Section 13: Laboratory Considerations | 2009-Aug-06 | 294.04 KB |
| Section 14: Data Collection | 2009-Aug-06 | 1.58 MB |
| Section 15: Data Communiques | 2009-Aug-06 | 14.24 KB |
| Section 15: Data Communiques #1 | 2009-Sep-08 | 51.22 KB |
| Section 15: Data Communiques #2 | 2009-Dec-16 | 36.78 KB |
| Section 16: ACASI Users Manual | 2009-Nov-04 | 890.42 KB |
| Section 17: Study Reporting Plan | 2009-Aug-06 | 44.69 KB |
| Section 18: Bone Mineral Density Substudy | 2009-Sep-23 | 1.94 MB |
| MTN-003B Data Communique #1 | 2009-Nov-23 | 34.63 KB |
