| Manual |
| Overview of Section Contents | 2012-Dec-12 | 113.56 KB |
| Section 01: Introduction | 2008-Jul-25 | 135.42 KB |
| Section 02: Protocol | 2012-Dec-12 | 34.68 KB |
| Section 03: Documentation Requirements | 2010-Apr-15 | 198.19 KB |
| Section 04: Participant Accrual | 2008-Jul-25 | 205.27 KB |
| Section 05: Participant Follow-up | 2012-Dec-12 | 230.56 KB |
| Section 06: Visit Checklists | 2010-Apr-15 | 245.88 KB |
| Section 07: Co-Enrollment Considerations | 2012-Dec-12 | 177.8 KB |
| Section 08: Clinical Considerations | 2008-Jul-25 | 280.38 KB |
| Section 09: Counseling Considerations | 2008-Jul-25 | 36.68 KB |
| Section 10: Laboratory Considerations | 2012-Apr-05 | 238.55 KB |
| Section 11: Safety Monitoring and Reporting | 2008-Jul-25 | 28.01 KB |
| Section 12: Data Collection | 2010-Oct-22 | 1.89 MB |
| Section 13: Data Communiques | 2008-Jul-25 | 12.01 KB |
| Section 13: Data Communiques #1 | 2009-Oct-29 | 38.66 KB |
| Section 13: Data Communiques #2 | 2010-Apr-19 | 24.18 KB |
| Section 13: Data Communiques #3 | 2013-Jan-07 | 22.45 KB |
| Section 13: Data Communiques #4 | 2013-Jan-08 | 22.93 KB |
| Section 13: Data Communiques #5 | 2013-Jan-25 | 31.63 KB |
| Section 13: Data Communiques #6 | 2013-Feb-28 | 20.86 KB |
| Section 14: Study Reporting Plan | 2010-Oct-22 | 24.28 KB |
