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Individual Sections
Overview and Control Document – Version History and Notice of Changes (Download) 2019-12-19983.71 KB
Table of Contents - Current Sections (Download) 2019-12-19213.7 KB
Section 01: Introduction (Download) 2019-12-19306.07 KB
Section 02: Documentation Requirements (Download) 2019-12-19343.88 KB
Section 03: Participant Accrual and Retention (Download) 2019-12-19301.77 KB
Section 04: Informed Consent (Download) 2019-12-19466.11 KB
Section 05: Study Procedures (Download) 2019-12-19715.6 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2019-12-19798.74 KB
Section 07: Clinical Considerations (Download) 2019-12-19947.26 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2019-12-191.04 MB
Section 09: Counseling Considerations (Download) 2019-12-19435.8 KB
Section 10: Laboratory Considerations (Download) 2019-12-191.04 MB
Section 11: Data Collection (Download) 2019-12-19707.87 KB
Section 12: Data Communiqués (Download) 2019-12-19133 KB
Section 13: Study Reporting Plan (Download) 2019-12-19302.26 KB
Section 14: DELIVER Qualitative Component (Download) 2019-12-19968.62 KB