Individual Sections| Overview and Control Document - Version History and Notice of Changes (Download) | 2019-03-19 | 761.45 KB |
| Table of Contents - Current Sections (Download) | 2018-12-20 | 372.21 KB |
| Section 01: Introduction (Download) | 2019-03-19 | 159.33 KB |
| Section 02: Documentation Requirements (Download) | 2018-12-20 | 394.08 KB |
| Section 03: Accrual and Retention (Download) | 2018-11-09 | 506.89 KB |
| Section 04: Informed Consent (Download) | 2018-11-09 | 516.08 KB |
| Section 05: Study Procedures (Download) | 2018-11-09 | 698.1 KB |
| Section 06: Behavioral Measures (Download) | 2018-12-20 | 1 MB |
| Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2018-11-09 | 766.87 KB |
| Section 08: Clinical Considerations (Download) | 2018-12-20 | 653.64 KB |
| Section 09: Adverse Event Reporting and Safety Monitoring (Download) | 2018-12-20 | 701.88 KB |
| Section 10: Laboratory Considerations (Download) | 2019-03-19 | 787.2 KB |
| Section 11: Counseling Procedures (Download) | 2018-11-09 | 424.9 KB |
| Section 12: Data Collection (Download) | 2018-12-20 | 628.34 KB |
| Section 13: Data Communiqués (Download) | 2018-11-09 | 209.64 KB |
| Section 14: Study Reporting Plan (Download) | 2018-11-09 | 572.2 KB |
