Individual Sections| Overview of Section Contents (Download) | 2017-03-24 | 204.27 KB |
| Section 01: Introduction (Download) | 2017-03-24 | 220.94 KB |
| Section 02: Documentation Requirements (Download) | 2017-03-24 | 254.25 KB |
| Section 03: Accrual and Retention (Download) | 2017-03-24 | 240.85 KB |
| Section 04: Informed Consent (Download) | 2017-03-24 | 412.69 KB |
| Section 05: Study Procedures (Download) | 2017-03-24 | 329.01 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2017-03-24 | 513.64 KB |
| Section 07: Clinical Considerations (Download) | 2017-03-24 | 403.44 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2017-03-24 | 273.69 KB |
| Section 09: Laboratory Considerations (Download) | 2017-03-24 | 614.09 KB |
| Section 10: Counseling Procedures (Download) | 2017-03-24 | 227.39 KB |
| Section 11: Data Collection (Download) | 2017-03-24 | 141.45 KB |
| Section 12: Data Communiqués (Download) | 2017-03-24 | 74.89 KB |
| Section 12: Data Communiqué #1 (Download) | 2017-07-14 | 27.96 KB |
| Section 13: Study Reporting Plan (Download) | 2017-03-24 | 90.85 KB |
