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Individual Sections
Overview of Section Contents (Download) 2018-05-25331.05 KB
Section 01: Introduction (Download) 2018-05-25318.1 KB
Section 02: Documentation Requirements (Download) 2018-05-25387.62 KB
Section 03: Accrual and Retention (Download) 2018-05-25345.14 KB
Section 04: Informed Consent (Download) 2018-05-25359.17 KB
Section 05: Study Procedures (Download) 2018-05-25573.33 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2018-05-25753.06 KB
Section 07: Behavioral Measures (Download) 2018-05-25502.46 KB
Section 08: Clinical Considerations (Download) 2018-05-25396.46 KB
Section 09: Adverse Event Reporting and Safety Monitoring (Download) 2018-05-25490.47 KB
Section 10: Laboratory Considerations (Download) 2018-05-25372.53 KB
Section 11: Counseling Procedures (Download) 2018-05-25198.54 KB
Section 12: Data Collection (Download) 2018-05-251.19 MB
Section 13: Data Communiqués (Download) 2018-05-25268.3 KB
Section 13: Data Communiqué #1 (Download) 2018-06-2727.78 KB
Section 14: Study Reporting Plan (Download) 2018-05-25236.55 KB