Individual Sections| Table of Contents - Current Sections (Download) | 2018-09-07 | 66.35 KB |
| Overview and Control Document - Version History and Notice of Changes (Download) | 2018-09-07 | 1004.14 KB |
| Section 01: Introduction (Download) | 2018-09-07 | 160.63 KB |
| Section 02: Documentation Requirements (Download) | 2018-09-07 | 417.26 KB |
| Section 03: Accrual and Retention (Download) | 2018-09-07 | 370.34 KB |
| Section 04: Informed Consent (Download) | 2018-09-07 | 435.25 KB |
| Section 05: Study Visit Procedures (Download) | 2018-09-07 | 603.86 KB |
| Section 06: Behavioral Assessments: CASI and IDI (Download) | 2018-09-07 | 344.88 KB |
| Section 07: Study Product Considerations (for non-pharmacy staff) (Download) | 2018-09-07 | 693.38 KB |
| Section 08: Clinical Considerations (Download) | 2018-09-07 | 560.04 KB |
| Section 09: AE Reporting and Safety Monitoring (Download) | 2018-09-07 | 615.93 KB |
| Section 10: Laboratory Considerations (Download) | 2018-09-07 | 810.72 KB |
| Section 11: Counseling Considerations (Download) | 2018-09-07 | 345.91 KB |
| Section 12: Data Collection (Download) | 2018-09-07 | 705 KB |
| Section 13: Data Communiques (Download) | 2018-09-07 | 134.97 KB |
| Section 13: Data Communiqué #1 (Download) | 2018-01-25 | 716.04 KB |
| Section 13: Data Communiqué #2 (Download) | 2018-02-21 | 428.04 KB |
| Section 13: Data Communiqué #3 (Download) | 2018-05-16 | 416.17 KB |
| Section 13: Data Communiqué #4 (Download) | 2018-08-01 | 317.19 KB |
| Section 14: Study Reporting Plan (Download) | 2018-09-07 | 230.27 KB |
