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Individual Sections
Table of Contents - Current Sections (Download) 2018-09-0766.35 KB
Overview and Control Document - Version History and Notice of Changes (Download) 2018-09-071004.14 KB
Section 01: Introduction (Download) 2018-09-07160.63 KB
Section 02: Documentation Requirements (Download) 2018-09-07417.26 KB
Section 03: Accrual and Retention (Download) 2018-09-07370.34 KB
Section 04: Informed Consent (Download) 2018-09-07435.25 KB
Section 05: Study Visit Procedures (Download) 2018-09-07603.86 KB
Section 06: Behavioral Assessments: CASI and IDI (Download) 2018-09-07344.88 KB
Section 07: Study Product Considerations (for non-pharmacy staff) (Download) 2018-09-07693.38 KB
Section 08: Clinical Considerations (Download) 2018-09-07560.04 KB
Section 09: AE Reporting and Safety Monitoring (Download) 2018-09-07615.93 KB
Section 10: Laboratory Considerations (Download) 2018-09-07810.72 KB
Section 11: Counseling Considerations (Download) 2018-09-07345.91 KB
Section 12: Data Collection (Download) 2018-09-07705 KB
Section 13: Data Communiques (Download) 2018-09-07134.97 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) 2018-09-07230.27 KB