| Manual |
| Overview of Section Contents | 2008-Sep-25 | 62.53 KB |
| Section 01: Introduction | 2008-Jul-24 | 135.42 KB |
| Section 02: Protocol | 2008-Aug-25 | 964.19 KB |
| Section 03: Documentation Requirements | 2008-Jul-24 | 266.45 KB |
| Section 04: Participant Accrual | 2008-Jul-24 | 205.27 KB |
| Section 05: Participant Follow-up | 2008-Jul-24 | 81.81 KB |
| Section 06: Visit Checklists | 2008-Jul-24 | 287.96 KB |
| Section 07: Co-Enrollment Considerations | 2008-Jul-24 | 48.22 KB |
| Section 08: Clinical Considerations | 2008-Jul-24 | 77.59 KB |
| Section 09: Counseling Considerations | 2008-Jul-24 | 36.68 KB |
| Section 10: Laboratory Considerations | 2008-Sep-25 | 355.12 KB |
| Section 11: Safety Monitoring and Reporting | 2008-Jul-24 | 28.01 KB |
| Section 12: Data Collection | 2008-Jul-24 | 1.24 MB |
| Section 13: Data Communiques | 2008-Jul-24 | 12.01 KB |
| Section 14: Study Reporting Plan | 2008-Jul-24 | 28.22 KB |