I. Study-Specific Procedures Manual (SSP) Sections VERSION 2| Overview and Version Control (Download) | 2012-01-26 | 197.49 KB |
| Table of Contents (Download) | 2011-05-02 | 103.54 KB |
| Section 01: Introduction (Download) | 2011-02-18 | 85.17 KB |
| Section 02: Protocol (Download) | 2011-02-18 | 1.05 MB |
| Section 03: Documentation Requirements (Download) | 2011-06-10 | 297.36 KB |
| Section 04: Participant Accrual (Download) | 2011-02-18 | 267.72 KB |
| Section 05: Informed Consent (Download) | 2011-02-18 | 317.23 KB |
| Section 06: Participant Follow-up (Download) | 2011-12-20 | 916.67 KB |
| Section 07: Visit Checklists (Download) | 2011-02-18 | 551.82 KB |
| Section 08: Participant Retention (Download) | 2011-02-18 | 50.21 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) | 2011-05-02 | 192.59 KB |
| Section 10: Clinical Considerations (Download) | 2011-06-10 | 489.23 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring (Download) | 2011-02-18 | 759.88 KB |
| Section 12: Counseling Considerations (Download) | 2011-09-22 | 761.02 KB |
| Section 13: Laboratory Considerations (Download) | 2011-09-22 | 992.49 KB |
| Section 14: Data Collection (Download) | 2011-02-18 | 1.54 MB |
| Section 15: Data Communiques (Download) | 2011-02-18 | 10.28 KB |
| Section 15: Data Communiques #4 (Download) | 2012-02-16 | 33.08 KB |
| Section 16: ACASI Users Manual (Download) | 2011-02-18 | 1.35 MB |
| Section 17: Study Reporting Plan (Download) | 2011-02-18 | 41.38 KB |
| Section 18: Bone Mineral Density Substudy (VOICE-B) (Download) | 2012-01-19 | 242.83 KB |
| Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) (Download) | 2012-01-26 | 357.29 KB |
II. Study-Specific Procedures Manual (SSP) Sections VERSION 1| Overview and Version Control (Download) | 2011-01-18 | 46.9 KB |
| Table of Contents (Download) | 2010-04-16 | 97.38 KB |
| Section 01: Introduction (Download) | 2009-08-07 | 84.26 KB |
| Section 02: Protocol (Download) | 2010-04-16 | 1.17 MB |
| Section 03: Documentation Requirements (Download) | 2009-08-07 | 156.49 KB |
| Section 04: Participant Accrual (Download) | 2010-11-24 | 202.9 KB |
| Section 05: Informed Consent (Download) | 2010-04-16 | 282.8 KB |
| Section 06: Participant Follow-up (Download) | 2010-11-24 | 329.72 KB |
| Section 07: Visit Checklists (Download) | 2010-04-16 | 1.2 MB |
| Section 08: Participant Retention (Download) | 2009-08-07 | 109.35 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) | 2010-04-16 | 270.62 KB |
| Section 10: Clinical Considerations (Download) | 2010-11-24 | 503.73 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring (Download) | 2010-04-16 | 213 KB |
| Section 12: Counseling Considerations (Download) | 2009-08-07 | 434.32 KB |
| Section 13: Laboratory Considerations (Download) | 2010-11-24 | 306.39 KB |
| Section 14: Data Collection (Download) | 2009-08-07 | 1.58 MB |
| Section 15: Data Communiques (Download) | 2009-08-07 | 14.24 KB |
| Section 15: Data Communiques #1 (Download) | 2009-09-09 | 51.22 KB |
| Section 15: Data Communiques #2 (Download) | 2009-12-16 | 36.78 KB |
| Section 15: Data Communiques #3 (Download) | 2010-04-16 | 331.94 KB |
| Section 16: ACASI Users Manual (Download) | 2010-11-24 | 1.14 MB |
| Section 17: Study Reporting Plan (Download) | 2009-08-07 | 44.69 KB |
| Section 18: Bone Mineral Density Substudy (VOICE-B) (Download) | 2010-07-21 | 235.94 KB |
| Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) (Download) | 2012-01-26 | 357.29 KB |
