SSP Manual - Individual Sections| Overview of Section Contents (Download) | 2016-02-23 | 193.26 KB |
| Section 01: Introduction (Download) | 2016-02-23 | 289.65 KB |
| Section 02: Documentation Requirements (Download) | 2015-02-25 | 449.8 KB |
| Section 03: Participant Accrual and Retention (Download) | 2015-02-25 | 354.13 KB |
| Section 04: Informed Assent and Consent (Download) | 2015-09-02 | 61.27 KB |
| Section 05: Study Procedures (Download) | 2016-02-23 | 432.15 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2015-04-07 | 693.24 KB |
| Section 07: Clinical Considerations (Download) | 2015-09-02 | 206.58 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2015-02-25 | 422.25 KB |
| Section 09: Counseling Procedures (Download) | 2015-02-25 | 327.32 KB |
| Section 10: Laboratory Considerations (Download) | 2015-04-07 | 903.31 KB |
| Section 11: Data Collection (Download) | 2016-02-01 | 582.99 KB |
| Section 12: Data Communiqués (Download) | 2015-02-25 | 90.46 KB |
| Section 12: Data Communiqués #1 (Download) | 2014-06-24 | 416.25 KB |
| Section 12: Data Communiqués #2 (Download) | 2015-03-02 | 337 KB |
| Section 12: Data Communiqués #3 (Download) | 2015-04-06 | 74.37 KB |
| Section 12: Data Communiqués #4 (Download) | 2015-10-02 | 49.28 KB |
| Section 13: Study Reporting Plan (Download) | 2016-02-01 | 218.77 KB |
| Section 14: Behavioral Measures (Download) | 2016-02-23 | 427.12 KB |
