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Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2021-07-021.18 MB
Table of Contents - Current Sections (Download) 2021-07-0261.97 KB
Section 01: Introduction (Download) 2021-07-02190.49 KB
Section 02: Documentation Requirements (Download) 2021-07-02216.82 KB
Section 03: Participant Accrual and Retention (Download) 2020-07-22207.6 KB
Section 04: Informed Assent and Consent (Download) 2021-07-02317.8 KB
Section 05: Study Procedures (Download) 2021-07-02380.81 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2021-01-05407.28 KB
Section 07: Clinical Considerations (Download) 2021-01-05392.38 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2021-07-02493.93 KB
Section 09: Laboratory Considerations (Download) 2021-01-05863.97 KB
Section 10: Counseling Procedures (Download) 2021-07-02314.19 KB
Section 11: Behavioral Assessments (Download) 2021-01-05812.12 KB
Section 12: Data Collection (Download) 2021-07-02525.25 KB
Section 13: Data Communiqués (Download) 2019-01-04132.51 KB
Section 13: Data Communiqué #1 (Download) 2018-11-01103.64 KB
Section 13: Data Communiqué #2 (Download) 2019-03-13115.04 KB
Section 13: Data Communiqué #3 (Download) 2019-05-23159.57 KB
Section 13: Data Communiqué #4 (Download) 2019-11-12125.68 KB
Section 13: Data Communiqué #5 (Download) 2020-02-1440.8 KB
Section 13: Data Communiqué #6 (Download) 2020-03-2735.98 KB
Section 13: Data Communiqué #7 (Download) 2020-07-22121.94 KB
Section 14: Study Reporting Plan (Download) 2020-07-22229.11 KB