Individual Sections| Overview and Control Document - Version History and Notice of Changes (Download) | 2020-06-01 | 864.65 KB |
| Table of Contents - Current Sections (Download) | 2020-06-01 | 227.76 KB |
| Section 01: Introduction (Download) | 2020-06-01 | 219.1 KB |
| Section 02: Documentation Requirements (Download) | 2020-06-01 | 331.71 KB |
| Section 03: Accrual and Retention (Download) | 2018-12-28 | 282.81 KB |
| Section 04: Informed Consent (Download) | 2018-12-28 | 530.39 KB |
| Section 05: Study Procedures (Download) | 2020-02-06 | 207.63 KB |
| Section 06: Study Product Considerations (Download) | 2019-09-30 | 352.15 KB |
| Section 07: Clinical Considerations (Download) | 2020-06-01 | 466.26 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2020-06-01 | 427.97 KB |
| Section 09: Laboratory Considerations (Download) | 2018-12-28 | 731.45 KB |
| Section 10: Counseling Procedures (Download) | 2019-09-30 | 174.06 KB |
| Section 11: Behavioral Measures (Download) | 2020-02-03 | 325.88 KB |
| Section 12: Data Collection (Download) | 2020-06-01 | 609.17 KB |
| Section 13: Data Communiqués (Download) | 2018-12-28 | 208.61 KB |
| Section 13: Data Communiqué #1 (Download) | 2019-09-05 | 50.72 KB |
| Section 13: Data Communiqué #2 (Download) | 2020-04-14 | 121.38 KB |
| Section 13: Data Communiqué #3 (Download) | 2020-06-09 | 24.44 KB |
| Section 14: Study Reporting Plan (Download) | 2020-06-01 | 266.75 KB |
