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Individual Sections
Overview of Section Contents (Download) 2018-08-13379.13 KB
Section 01: Introduction (Download) 2018-08-13325.74 KB
Section 02: Documentation Requirements (Download) 2018-03-26690.88 KB
Section 03: Accrual and Retention (Download) 2018-03-26513.79 KB
Section 04: Informed Consent (Download) 2018-03-26616.91 KB
Section 05: Study Procedures (Download) 2018-03-26431.95 KB
Section 06: Study Product Considerations for Non- Pharmacy Staff (Download) 2018-08-13458.15 KB
Section 07: Clinical Considerations (Download) 2018-08-13658.11 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2018-03-26917.23 KB
Section 09: Laboratory Considerations (Download) 2018-03-26785.21 KB
Section 10: Counseling Considerations (Download) 2018-08-13279.38 KB
Section 11: Behavioral Measures (Download) 2018-08-13837.17 KB
Section 12: Data Collection (Download) 2018-03-26836.72 KB
Section 13: Data Communiqués (Download) 2018-03-26186.95 KB
Section 13: Data Communiqué #1 (Download) 2018-06-2143.62 KB
Section 13: Data Communiqué #2 (Download) 2018-06-2733.43 KB
Section 13: Data Communiqué #3 (Download) 2018-08-1046.24 KB
Section 14: Study Reporting Plan (Download) 2018-03-26284.47 KB