Individual Sections| Overview and Control Document - Version History and Notice of Changes (Download) | 2018-10-05 | 542.1 KB |
| Table of Contents - Current Sections (Download) | 2018-10-05 | 373.12 KB |
| Section 01: Introduction (Download) | 2018-10-05 | 258.7 KB |
| Section 02: Documentation Requirements (Download) | 2018-10-05 | 418.05 KB |
| Section 03: Accrual and Retention (Download) | 2018-10-05 | 214.31 KB |
| Section 04: Informed Consent (Download) | 2018-10-05 | 439.35 KB |
| Section 05: Study Procedures (Download) | 2018-10-05 | 454.07 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2018-10-05 | 764.06 KB |
| Section 07: Behavioral Measures (Download) | 2018-10-05 | 534.35 KB |
| Section 08: Clinical Considerations (Download) | 2018-10-05 | 784.42 KB |
| Section 09: Adverse Event Reporting and Safety Monitoring (Download) | 2018-10-05 | 608.17 KB |
| Section 10: Laboratory Considerations (Download) | 2018-10-05 | 823.41 KB |
| Section 11: Counseling Procedures (Download) | 2018-10-05 | 344.23 KB |
| Section 12: Data Collection (Download) | 2018-10-05 | 959.78 KB |
| Section 13: Data Communiqués (Download) | 2018-10-05 | 268.59 KB |
| Section 13: Data Communiqué #1 (Download) | 2018-06-27 | 27.78 KB |
| Section 13: Data Communiqué #2 (Download) | 2018-08-31 | 39.56 KB |
| Section 13: Data Communiqué #3 (Download) | 2018-11-13 | 155.76 KB |
| Section 13: Data Communiqué #4 (Download) | 2019-01-08 | 141.05 KB |
| Section 14: Study Reporting Plan (Download) | 2018-10-05 | 401.92 KB |
