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Individual Sections
Overview and Control Document – Version History and Notice of Changes (Download) 2020-06-301.29 MB
Table of Contents - Current Sections (Download) 2020-06-30101.58 KB
Section 01: Introduction (Download) 2020-06-30187.96 KB
Section 02: Documentation Requirements (Download) 2019-12-19343.88 KB
Section 03: Participant Accrual and Retention (Download) 2020-06-30198.56 KB
Section 04: Informed Consent (Download) 2019-12-19466.11 KB
Section 05: Study Procedures (Download) 2020-06-30557.19 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2020-04-09689.44 KB
Section 07: Clinical Considerations (Download) 2020-04-09824.52 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2020-06-30880.93 KB
Section 09: Counseling Considerations (Download) 2020-04-09289.5 KB
Section 10: Laboratory Considerations (Download) 2020-06-30817.17 KB
Section 11: Data Collection (Download) 2020-06-30726.43 KB
Section 12: Data Communiqués (Download) 2019-12-19133 KB
Section 12: Data Communiqué #1 (Download) 2020-02-0568.45 KB
Section 13: Study Reporting Plan (Download) 2019-12-19302.26 KB
Section 14: DELIVER Qualitative Component (Download) 2020-04-09673.05 KB