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I. Study-Specific Procedures Manual (SSP) Sections VERSION 2
Overview and Version Control (Download) 2012-01-26197.49 KB
Table of Contents (Download) 2011-05-02103.54 KB
Section 01: Introduction (Download) 2011-02-1885.17 KB
Section 02: Protocol (Download) 2011-02-181.05 MB
Section 03: Documentation Requirements (Download) 2011-06-10297.36 KB
Section 04: Participant Accrual (Download) 2011-02-18267.72 KB
Section 05: Informed Consent (Download) 2011-02-18317.23 KB
Section 06: Participant Follow-up (Download) 2011-12-20916.67 KB
Section 07: Visit Checklists (Download) 2011-02-18551.82 KB
Section 08: Participant Retention (Download) 2011-02-1850.21 KB
Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) 2011-05-02192.59 KB
Section 10: Clinical Considerations (Download) 2011-06-10489.23 KB
Section 11: Adverse Event Reporting and Safety Monitoring (Download) 2011-02-18759.88 KB
Section 12: Counseling Considerations (Download) 2011-09-22761.02 KB
Section 13: Laboratory Considerations (Download) 2011-09-22992.49 KB
Section 14: Data Collection (Download) 2011-02-181.54 MB
Section 15: Data Communiques (Download) 2011-02-1810.28 KB
Section 15: Data Communiques #4 (Download) 2012-02-1633.08 KB
Section 16: ACASI Users Manual (Download) 2011-02-181.35 MB
Section 17: Study Reporting Plan (Download) 2011-02-1841.38 KB
Section 18: Bone Mineral Density Substudy (VOICE-B) (Download) 2012-01-19242.83 KB
Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) (Download) 2012-01-26357.29 KB
II. Study-Specific Procedures Manual (SSP) Sections VERSION 1
Overview and Version Control (Download) 2011-01-1846.9 KB
Table of Contents (Download) 2010-04-1697.38 KB
Section 01: Introduction (Download) 2009-08-0784.26 KB
Section 02: Protocol (Download) 2010-04-161.17 MB
Section 03: Documentation Requirements (Download) 2009-08-07156.49 KB
Section 04: Participant Accrual (Download) 2010-11-24202.9 KB
Section 05: Informed Consent (Download) 2010-04-16282.8 KB
Section 06: Participant Follow-up (Download) 2010-11-24329.72 KB
Section 07: Visit Checklists (Download) 2010-04-161.2 MB
Section 08: Participant Retention (Download) 2009-08-07109.35 KB
Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) 2010-04-16270.62 KB
Section 10: Clinical Considerations (Download) 2010-11-24503.73 KB
Section 11: Adverse Event Reporting and Safety Monitoring (Download) 2010-04-16213 KB
Section 12: Counseling Considerations (Download) 2009-08-07434.32 KB
Section 13: Laboratory Considerations (Download) 2010-11-24306.39 KB
Section 14: Data Collection (Download) 2009-08-071.58 MB
Section 15: Data Communiques (Download) 2009-08-0714.24 KB
Section 15: Data Communiques #1 (Download) 2009-09-0951.22 KB
Section 15: Data Communiques #2 (Download) 2009-12-1636.78 KB
Section 15: Data Communiques #3 (Download) 2010-04-16331.94 KB
Section 16: ACASI Users Manual (Download) 2010-11-241.14 MB
Section 17: Study Reporting Plan (Download) 2009-08-0744.69 KB
Section 18: Bone Mineral Density Substudy (VOICE-B) (Download) 2010-07-21235.94 KB
Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) (Download) 2012-01-26357.29 KB