| Complete Manual |
| MTN-001 SSP - All Sections | 2009-Dec-18 | 10.34 MB |
| Individual Sections |
| Overview of Section Contents and Identification of Current Section Versions | 2009-Nov-23 | 73.85 KB |
| Table of Contents | 2008-Oct-16 | 68.22 KB |
| Section 01: Introduction | 2008-Oct-16 | 123.29 KB |
| Section 02: Protocol | 2008-Oct-16 | 1.02 MB |
| Section 03: Documentation Requirements | 2008-Nov-05 | 200.46 KB |
| Section 04: Participant Accrual | 2009-Aug-09 | 3.49 MB |
| Section 05: Informed Consent | 2008-Oct-16 | 167.95 KB |
| Section 06: Participant Follow-up | 2009-Aug-09 | 365.72 KB |
| Section 07: Non-US Visit Checklists | 2009-Sep-17 | 288.45 KB |
| Section 07: US Visit Checklists | 2009-Sep-17 | 288 KB |
| Section 08: Participant Retention | 2009-Sep-02 | 42.41 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff | 2009-May-17 | 123.94 KB |
| Section 10: Clinical Considerations | 2009-Aug-23 | 306.49 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2008-Oct-16 | 163.32 KB |
| Section 12: Laboratory Considerations | 2009-Nov-13 | 1.14 MB |
| Section 13: Data Collection | 2008-Nov-05 | 1.88 MB |
| Section 14: Data Communique | 2008-Oct-16 | 14.23 KB |
| Section 14: Data Communique #1 | 2008-Jun-17 | 24.36 KB |
| Section 14: Data Communique #2 | 2008-Oct-27 | 38.63 KB |
| Section 14: Data Communique #3 | 2008-Nov-07 | 28.92 KB |
| Section 14: Data Communique #4 | 2009-Mar-26 | 36.25 KB |
| Section 14: Data Communique #5 REVISED | 2009-Sep-02 | 52.04 KB |
| Section 14: Data Communique #6 | 2009-Dec-18 | 35.38 KB |
| Section 15: Study Reporting Plan | 2008-Oct-16 | 38.9 KB |
| Section 16: Week 21 In-Depth Interviews | 2009-Aug-27 | 222.17 KB |
