| I. Study-Specific Procedures Manual (SSP) Sections VERSION 2 |
| Overview and Version Control | 2012-Jan-26 | 197.49 KB |
| Table of Contents | 2011-May-02 | 103.54 KB |
| Section 01: Introduction | 2011-Feb-18 | 85.17 KB |
| Section 02: Protocol | 2011-Feb-18 | 1.05 MB |
| Section 03: Documentation Requirements | 2011-Jun-10 | 297.36 KB |
| Section 04: Participant Accrual | 2011-Feb-18 | 267.72 KB |
| Section 05: Informed Consent | 2011-Feb-18 | 317.23 KB |
| Section 06: Participant Follow-up | 2011-Dec-20 | 916.67 KB |
| Section 07: Visit Checklists | 2011-Feb-18 | 551.82 KB |
| Section 08: Participant Retention | 2011-Feb-18 | 50.21 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff | 2011-May-02 | 192.59 KB |
| Section 10: Clinical Considerations | 2011-Jun-10 | 489.23 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2011-Feb-18 | 759.88 KB |
| Section 12: Counseling Considerations | 2011-Sep-22 | 761.02 KB |
| Section 13: Laboratory Considerations | 2011-Sep-22 | 992.49 KB |
| Section 14: Data Collection | 2011-Feb-18 | 1.54 MB |
| Section 15: Data Communiques | 2011-Feb-18 | 10.28 KB |
| Section 15: Data Communiques #4 | 2012-Feb-16 | 33.08 KB |
| Section 16: ACASI Users Manual | 2011-Feb-18 | 1.35 MB |
| Section 17: Study Reporting Plan | 2011-Feb-18 | 41.38 KB |
| Section 18: Bone Mineral Density Substudy (VOICE-B) | 2012-Jan-19 | 242.83 KB |
| Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) | 2012-Jan-26 | 357.29 KB |
| II. Study-Specific Procedures Manual (SSP) Sections VERSION 1 |
| Overview and Version Control | 2011-Jan-18 | 46.9 KB |
| Table of Contents | 2010-Apr-16 | 97.38 KB |
| Section 01: Introduction | 2009-Aug-07 | 84.26 KB |
| Section 02: Protocol | 2010-Apr-16 | 1.17 MB |
| Section 03: Documentation Requirements | 2009-Aug-07 | 156.49 KB |
| Section 04: Participant Accrual | 2010-Nov-24 | 202.9 KB |
| Section 05: Informed Consent | 2010-Apr-16 | 282.8 KB |
| Section 06: Participant Follow-up | 2010-Nov-24 | 329.72 KB |
| Section 07: Visit Checklists | 2010-Apr-16 | 1.2 MB |
| Section 08: Participant Retention | 2009-Aug-07 | 109.35 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff | 2010-Apr-16 | 270.62 KB |
| Section 10: Clinical Considerations | 2010-Nov-24 | 503.73 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2010-Apr-16 | 213 KB |
| Section 12: Counseling Considerations | 2009-Aug-07 | 434.32 KB |
| Section 13: Laboratory Considerations | 2010-Nov-24 | 306.39 KB |
| Section 14: Data Collection | 2009-Aug-07 | 1.58 MB |
| Section 15: Data Communiques | 2009-Aug-07 | 14.24 KB |
| Section 15: Data Communiques #1 | 2009-Sep-09 | 51.22 KB |
| Section 15: Data Communiques #2 | 2009-Dec-16 | 36.78 KB |
| Section 15: Data Communiques #3 | 2010-Apr-16 | 331.94 KB |
| Section 16: ACASI Users Manual | 2010-Nov-24 | 1.14 MB |
| Section 17: Study Reporting Plan | 2009-Aug-07 | 44.69 KB |
| Section 18: Bone Mineral Density Substudy (VOICE-B) | 2012-Jan-19 | 242.83 KB |
| Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) | 2012-Jan-26 | 357.29 KB |
