Individual Sections| Overview and Control Document - Version History and Notice of Changes (Download) | 2018-11-06 | 304.85 KB |
| Table of Contents - Current Sections (Download) | 2018-11-05 | 60.95 KB |
| Section 01: Introduction (Download) | 2018-11-05 | 190.76 KB |
| Section 02: Documentation Requirements (Download) | 2018-11-05 | 365.65 KB |
| Section 03: Accrual and Retention (Download) | 2018-11-05 | 204.93 KB |
| Section 04: Informed Consent (Download) | 2018-11-05 | 426.4 KB |
| Section 05: Study Procedures (Download) | 2018-11-05 | 297.05 KB |
| Section 06: Study Product Considerations for Non- Pharmacy Staff (Download) | 2018-11-05 | 460.15 KB |
| Section 07: Clinical Considerations (Download) | 2018-11-05 | 516.73 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2018-11-05 | 703.25 KB |
| Section 09: Laboratory Considerations (Download) | 2018-11-05 | 545.39 KB |
| Section 10: Counseling Considerations (Download) | 2018-11-05 | 205.38 KB |
| Section 11: Behavioral Measures (Download) | 2018-11-05 | 330.82 KB |
| Section 12: Data Collection (Download) | 2018-11-05 | 838.85 KB |
| Section 13: Data Communiqués (Download) | 2018-11-05 | 145.62 KB |
| Section 13: Data Communiqué #1 (Download) | 2018-06-21 | 43.62 KB |
| Section 13: Data Communiqué #2 (Download) | 2018-06-27 | 33.43 KB |
| Section 13: Data Communiqué #3 (Download) | 2018-08-10 | 46.24 KB |
| Section 13: Data Communiqué #4 (Download) | 2018-09-11 | 31.32 KB |
| Section 14: Study Reporting Plan (Download) | 2018-11-05 | 231.57 KB |
