Individual Sections| Overview and Version Control (Download) | 2017-07-07 | 485.67 KB |
| Table of Contents (Download) | 2009-11-16 | 69.07 KB |
| Section 01: Introduction v2.1 (Download) | 2017-07-07 | 172.42 KB |
| Section 02: Protocol v2.0 (Download) | 2014-04-01 | 34.47 KB |
| Section 03: Documentation Requirements v2.2 (Download) | 2017-07-07 | 318.46 KB |
| Section 04: Participant Accrual v2.3 (Download) | 2017-07-07 | 306.62 KB |
| Section 05: Informed Consent v2.0 (Download) | 2014-04-01 | 304.39 KB |
| Section 06: Particpant Follow Up v2.0 (Download) | 2014-04-01 | 188.51 KB |
| Section 07: Visit Checklists v2.0 (Download) | 2014-04-01 | 476.02 KB |
| Section 08: Co-Enrollment Considerations v2.1 (Download) | 2017-07-07 | 51.2 KB |
| Section 09: Participant Retention v2.0 (Download) | 2014-04-01 | 187.08 KB |
| Section 10: Clinical Considerations v2.0 (Download) | 2014-04-01 | 707.67 KB |
| Section 11: Safety Monitoring and Reporting v2.0 (Download) | 2014-04-01 | 121.5 KB |
| Section 12: Laboratory Considerations v2.1 (Download) | 2017-07-17 | 452.75 KB |
| Section 13: Data Management v2.2 (Download) | 2017-06-02 | 1.66 MB |
| Section 14: Data Communiques v2.0 (Download) | 2014-05-01 | 120.74 KB |
| Section 14: Data Communique #1 (Download) | 2011-04-07 | 69.2 KB |
| Section 14: Data Communique #2 (Download) | 2013-02-22 | 131.02 KB |
| Section 14: Data Communique #3 (Download) | 2013-08-13 | 207.49 KB |
| Section 14: Data Communique #4 (Download) | 2014-05-01 | 684.55 KB |
| Section 14: Data Communique #5 (Download) | 2015-09-14 | 225.55 KB |
| Section 14: Data Communique #6 (Download) | 2017-06-06 | 379.66 KB |
| Section 15: Study Reporting Plan v2.0 (Download) | 2014-05-01 | 254.24 KB |
SSP Manual - Archived Sections| Overview and Version Control (Download) | 2013-06-25 | 114.03 KB |
| Overview and Version Control (Download) | 2015-09-16 | 288.73 KB |
| Section 01: Introduction v1.0 (Download) | 2009-11-16 | 95.32 KB |
| Section 02: Protocol v1.0 (Download) | 2009-11-16 | 518.54 KB |
| Section 03: Documentation Requirements v1.0 (Download) | 2009-11-16 | 197.14 KB |
| Section 03: Documentation Requirements v1.1 (Download) | 2011-12-01 | 190 KB |
| Section 03: Documentation Requirements v1.2 (Download) | 2013-02-04 | 220.97 KB |
| Section 03: Documentation Requirements v2.0 (Download) | 2014-04-01 | 247.82 KB |
| Section 04: Participant Accrual v1.0 (Download) | 2009-11-16 | 37.37 KB |
| Section 04: Participant Accrual v1.1 (Download) | 2010-06-09 | 85.16 KB |
| Section 04: Participant Accrual v1.2 (Download) | 2012-01-13 | 42.54 KB |
| Section 04: Participant Accrual v2.1 (Download) | 2015-05-04 | 298.89 KB |
| Section 05: Informed Consent v1.0 (Download) | 2009-11-16 | 159.05 KB |
| Section 06: Particpant Follow Up v1.0 (Download) | 2009-11-16 | 93.44 KB |
| Section 06: Particpant Follow Up v1.1 (Download) | 2013-02-04 | 142.65 KB |
| Section 07: Visit Checklists v1.0 (Download) | 2009-11-16 | 672.91 KB |
| Section 08: Co-Enrollment Considerations v1.0 (Download) | 2009-11-16 | 80.96 KB |
| Section 09: Participant Retention v1.0 (Download) | 2009-11-16 | 98.57 KB |
| Section 09: Participant Retention v1.1 (Download) | 2013-02-04 | 139.39 KB |
| Section 10: Clinical Considerations v1.0 (Download) | 2009-11-16 | 448.73 KB |
| Section 10: Clinical Considerations v1.1 (Download) | 2011-05-25 | 495.08 KB |
| Section 10: Clinical Considerations v1.2 (Download) | 2011-12-01 | 429.73 KB |
| Section 10: Clinical Considerations v1.3 (Download) | 2013-02-04 | 556.13 KB |
| Section 11: Safety Monitoring and Reporting v1.0 (Download) | 2009-11-16 | 28.34 KB |
| Section 11: Safety Monitoring and Reporting v1.1 (Download) | 2010-06-09 | 77.8 KB |
| Section 11: Safety Monitoring and Reporting v1.2 (Download) | 2011-12-01 | 45.16 KB |
| Section 12: Laboratory Considerations v1.0 (Download) | 2009-11-16 | 648.73 KB |
| Section 12: Laboratory Considerations v1.1 (Download) | 2011-11-23 | 230.5 KB |
| Section 12: Laboratory Considerations v1.2 (Download) | 2011-12-09 | 155.65 KB |
| Section 12: Laboratory Considerations v1.3 (Download) | 2013-02-04 | 365.76 KB |
| Section 12: Laboratory Considerations v1.4 (Download) | 2013-03-20 | 364.71 KB |
| Section 13: Data Collection v1.0 (Download) | 2009-07-29 | 1.18 MB |
| Section 13: Data Management v2.0 (Download) | 2014-05-01 | 2.02 MB |
| Section 13: Data Management v2.1 (Download) | 2015-09-16 | 1.32 MB |
| Section 14: Data Communiques v1.0 (Download) | 2009-06-16 | 9.7 KB |
| Section 15: Study Reporting Plan v1.0 (Download) | 2009-06-16 | 21.89 KB |
