Individual Sections| Table of Contents – Current Sections (Download) | 2021-01-29 | 215.68 KB |
| Overview and Control Document – Version History and Notice of Changes (Download) | 2021-01-29 | 1.03 MB |
| Section 01: Introduction (Download) | 2020-04-30 | 302.11 KB |
| Section 02: Documentation Requirements (Download) | 2020-04-30 | 322.04 KB |
| Section 03: Participant Accrual and Retention (Download) | 2020-04-30 | 291.49 KB |
| Section 04: Informed Consent (Download) | 2020-04-30 | 458 KB |
| Section 05: Study Procedures (Download) | 2021-01-29 | 627.42 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2020-04-30 | 544.52 KB |
| Section 07: Clinical Considerations (Download) | 2021-01-29 | 901.24 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2020-04-30 | 908.02 KB |
| Section 09: Counseling Considerations (Download) | 2020-04-30 | 400.88 KB |
| Section 10: Laboratory Considerations (Download) | 2021-01-29 | 1.22 MB |
| Section 11: Data Collection (Download) | 2021-01-29 | 779.98 KB |
| Section 12: Data Communiqués (Download) | 2020-04-30 | 153.66 KB |
| Section 13: Study Reporting Plan (Download) | 2020-04-30 | 312.03 KB |
| Section 14: B-PROTECTED Qualitative Component (Download) | 2021-01-29 | 864.11 KB |
