| Overview of Sections | 2008-Nov-05 | 80.02 KB |
| Table of Contents | 2008-Aug-05 | 40.95 KB |
| Manual |
| Section 01 Introduction | 2008-Nov-05 | 120.68 KB |
| Section 02 Protocol | 2008-Aug-05 | 1.08 MB |
| Section 03 Documentation Requirements | 2008-Aug-19 | 321.03 KB |
| Section 04 Participant Accrual | 2008-Aug-05 | 1.08 MB |
| Section 05 Informed Consent | 2008-Aug-05 | 154.06 KB |
| Section 06 Participant Follow-Up | 2008-Aug-05 | 153.52 KB |
| Section 07 Visit Checklists | 2008-Aug-05 | 322.31 KB |
| Section 08 Participant Retention | 2008-Aug-05 | 105.03 KB |
| Section 09 Study Product Considerations for Non-Pharmacy Staff | 2008-Oct-14 | 931.2 KB |
| Section 10 Clinical Considerations | 2008-Oct-27 | 262.03 KB |
| Section 11 Adverse Event Reporting and Safety Monitoring | 2008-Oct-14 | 739.58 KB |
| Section 12 Laboratory Considerations | 2008-Aug-05 | 137.17 KB |
| Section 13 Behavioral Measures | 2008-Aug-05 | 580.73 KB |
| Section 14 Data Collection | 2008-Aug-26 | 1.79 MB |
| Section 15 Data Communiques | 2008-Jul-24 | 14.25 KB |
| Section 15: Data Communique #1 | 2008-Jul-30 | 27.62 KB |
| Section 15: Data Communique #2 | 2008-Nov-12 | 23.97 KB |
| Section 16 Study Reporting Plan | 2008-Aug-05 | 38.93 KB |