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Individual Sections
Overview of Section Contents (Download) 2018-05-22444.18 KB
Section 01: Introduction (Download) 2018-05-22153.93 KB
Section 02: Documentation Requirements (Download) 2018-05-22267.68 KB
Section 03: Accrual and Retention (Download) 2017-10-04389.15 KB
Section 04: Informed Consent (Download) 2017-10-04437.16 KB
Section 05: Study Visit Procedures (Download) 2018-05-22520.03 KB
Section 06: Behavioral Assessments: CASI and IDI (Download) 2018-05-22677.32 KB
Section 07: Study Product Considerations (for non-pharmacy staff) (Download) 2017-10-04573.11 KB
Section 08: Clinical Considerations (Download) 2018-05-22509.09 KB
Section 09: AE Reporting and Safety Monitoring (Download) 2017-10-04467.69 KB
Section 10: Laboratory Considerations (Download) 2018-02-19782.07 KB
Section 11: Counseling Considerations (Download) 2018-05-22470.58 KB
Section 12: Data Collection (Download) 2017-10-04657.68 KB
Section 13: Data Communiques (Download) 2017-10-04134.92 KB
Section 13: Data Communiqué #1 (Download) 2018-01-25716.04 KB
Section 13: Data Communiqué #2 (Download) 2018-02-21428.04 KB
Section 13: Data Communiqué #3 (Download) 2018-05-16416.17 KB
Section 13: Data Communiqué #4 (Download) 2018-08-01317.19 KB
Section 14: Study Reporting Plan (Download) 2017-10-04228.7 KB