Individual Sections| Overview of Sections (Download) | 2009-09-11 | 78.15 KB |
| Table of Contents (Download) | 2008-08-06 | 40.95 KB |
| Section 01 Introduction (Download) | 2009-06-03 | 49.89 KB |
| Section 02 Protocol (Download) | 2009-06-03 | 2.14 MB |
| Section 03 Documentation Requirements (Download) | 2009-06-03 | 237.97 KB |
| Section 04 Participant Accrual (Download) | 2009-06-03 | 1.07 MB |
| Section 05 Informed Consent (Download) | 2009-06-03 | 149.61 KB |
| Section 06 Participant Follow-Up (Download) | 2009-06-29 | 73.68 KB |
| Section 07 Visit Checklists (Download) | 2009-07-30 | 248.07 KB |
| Section 08 Participant Retention (Download) | 2008-08-06 | 105.03 KB |
| Section 09 Study Product Considerations for Non-Pharmacy Staff (Download) | 2008-10-15 | 931.2 KB |
| Section 10: Clinical Considerations (Download) | 2009-06-03 | 294.09 KB |
| Section 11 Adverse Event Reporting and Safety Monitoring (Download) | 2009-09-11 | 891.81 KB |
| Section 12 Laboratory Considerations (Download) | 2009-06-29 | 194.58 KB |
| Section 13 Behavioral Measures (Download) | 2009-06-03 | 694.76 KB |
| Section 14 Data Collection (Download) | 2009-06-03 | 1.52 MB |
| Section 15 Data Communiques (Download) | 2008-08-06 | 14.25 KB |
| Section 15: Data Communique #1 (Download) | 2008-07-31 | 27.62 KB |
| Section 15: Data Communique #2 (Download) | 2008-11-12 | 23.97 KB |
| Section 15: Data Communique #3 (Download) | 2009-07-28 | 23.44 KB |
| Section 16 Study Reporting Plan (Download) | 2009-06-03 | 24.94 KB |
