| SSP Manual |
| Overview and Version Control | 2012-Jan-13 | 24.51 KB |
| Table of Contents | 2009-Nov-16 | 69.07 KB |
| Section 01: Introduction | 2009-Nov-16 | 95.32 KB |
| Section 02: Protocol | 2009-Nov-16 | 518.54 KB |
| Section 03: Documentation Requirements v1.1 | 2011-Dec-01 | 190 KB |
| Section 04: Participant Accrual v1.2 | 2012-Jan-13 | 42.54 KB |
| Section 05: Informed Consent | 2009-Nov-16 | 159.05 KB |
| Section 06: Particpant Follow Up | 2009-Nov-16 | 93.44 KB |
| Section 07: Visit Checklists | 2009-Nov-16 | 672.91 KB |
| Section 08: Co-Enrollment Considerations | 2009-Nov-16 | 80.96 KB |
| Section 09: Participant Retention | 2009-Nov-16 | 98.57 KB |
| Section 10: Clinical Considerations v1.2 | 2011-Dec-01 | 429.73 KB |
| Section 11: Safety Monitoring and Reporting v1.2 | 2011-Dec-01 | 45.16 KB |
| Section 12: Laboratory Considerations v1.2 | 2011-Dec-09 | 155.65 KB |
| Section 13: Data Collection | 2009-Jul-28 | 1.18 MB |
| Section 14: Data Communiques | 2009-Jun-15 | 9.7 KB |
| Section 14: Data Communique #1 | 2011-Apr-07 | 69.2 KB |
| Section 15: Study Reporting Plan | 2009-Jun-16 | 21.89 KB |
| SSP Manual - Archived Sections |
| Section 03: Documentation Requirements v1.0 | 2009-Nov-16 | 197.14 KB |
| Section 04: Participant Accrual v1.1 | 2010-Jun-09 | 85.16 KB |
| Section 10: Clinical Considerations v1.1 | 2011-May-25 | 495.08 KB |
| Section 11: Safety Monitoring and Reporting v1.1 | 2010-Jun-09 | 77.8 KB |
| Section 12: Laboratory Considerations v1.0 | 2009-Nov-16 | 648.73 KB |
| Section 12: Laboratory Considerations v1.1 | 2011-Nov-23 | 230.5 KB |