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Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2018-11-06304.85 KB
Table of Contents - Current Sections (Download) 2018-11-0560.95 KB
Section 01: Introduction (Download) 2018-11-05190.76 KB
Section 02: Documentation Requirements (Download) 2018-11-05365.65 KB
Section 03: Accrual and Retention (Download) 2018-11-05204.93 KB
Section 04: Informed Consent (Download) 2018-11-05426.4 KB
Section 05: Study Procedures (Download) 2018-11-05297.05 KB
Section 06: Study Product Considerations for Non- Pharmacy Staff (Download) 2018-11-05460.15 KB
Section 07: Clinical Considerations (Download) 2018-11-05516.73 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2018-11-05703.25 KB
Section 09: Laboratory Considerations (Download) 2018-11-05545.39 KB
Section 10: Counseling Considerations (Download) 2018-11-05205.38 KB
Section 11: Behavioral Measures (Download) 2018-11-05330.82 KB
Section 12: Data Collection (Download) 2018-11-05838.85 KB
Section 13: Data Communiqués (Download) 2018-11-05145.62 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 13: Data Communiqué #4 (Download) 2018-09-1131.32 KB
Section 14: Study Reporting Plan (Download) 2018-11-05231.57 KB