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Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2019-09-303.01 MB
Table of Contents - Current Sections (Download) 2019-09-30113.13 KB
Section 01: Introduction (Download) 2019-09-30149.53 KB
Section 02: Documentation Requirements (Download) 2019-09-30194.41 KB
Section 03: Accrual and Retention (Download) 2018-12-28282.81 KB
Section 04: Informed Consent (Download) 2018-12-28530.39 KB
Section 05: Study Procedures (Download) 2019-09-30212.85 KB
Section 06: Study Product Considerations (Download) 2019-09-30352.15 KB
Section 07: Clinical Considerations (Download) 2019-09-30282.06 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2018-12-28419.14 KB
Section 09: Laboratory Considerations (Download) 2018-12-28731.45 KB
Section 10: Counseling Procedures (Download) 2019-09-30174.06 KB
Section 11: Behavioral Measures (Download) 2019-09-30350.08 KB
Section 12: Data Collection (Download) 2019-09-30443.16 KB
Section 13: Data Communiqués (Download) 2018-12-28208.61 KB
Section 13: Data Communiqué #1 (Download) 2019-09-0550.72 KB
Section 14: Study Reporting Plan (Download) 2018-12-28345.77 KB