Individual Sections| Overview and Version Control (Download) | 2012-03-05 | 85.82 KB |
| Section 01: Introduction (Download) | 2011-04-25 | 81.89 KB |
| Section 02: Protocol (Download) | 2011-04-25 | 591.27 KB |
| Section 03: Documentation Requirements (Download) | 2011-04-25 | 164.34 KB |
| Section 04: Participant Accrual (Download) | 2011-04-25 | 375.15 KB |
| Section 05: Informed Consent (Download) | 2011-04-25 | 254.13 KB |
| Section 06: Participant Follow-up (Download) | 2012-03-05 | 411.85 KB |
| Section 07: Visit Checklists (Download) | 2011-04-25 | 59.44 KB |
| Section 08: Participant Retention (Download) | 2011-04-25 | 97.71 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) | 2011-04-25 | 322 KB |
| Section 10: Clinical Considerations (Download) | 2011-04-25 | 227.46 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring (Download) | 2011-04-25 | 245.14 KB |
| Section 12: Laboratory Considerations (Download) | 2011-12-28 | 449.45 KB |
| Section 13: Data Collection (Download) | 2011-12-01 | 738.66 KB |
| Section 14: Counseling Considerations (Download) | 2011-04-25 | 135.96 KB |
| Section 15: Data Communiqué (Download) | 2011-04-25 | 10.45 KB |
| Section 15: Data Communiqué #1 (Download) | 2011-07-08 | 20.83 KB |
| Section 15: Data Communiqué #2 (Download) | 2011-11-15 | 20.64 KB |
| Section 15: Data Communiqué #3 (Download) | 2012-02-09 | 23.64 KB |
| Section 16: ACASI Users’ Manual (Download) | 2011-04-25 | 1.61 MB |
| Section 17: Study Reporting Plan (Download) | 2011-04-25 | 23.61 KB |
