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DescriptionDateSize
Individual Sections
Overview and Control Document – Version History and Notice of Changes (Download) 2022-05-101.31 MB
Table of Contents - Current Sections (Download) 2022-05-1068.87 KB
Section 01: Introduction (Download) 2022-05-10135.22 KB
Section 02: Documentation Requirements (Download) 2021-08-24232.16 KB
Section 03: Participant Accrual and Retention (Download) 2022-05-10202.16 KB
Section 04: Informed Consent (Download) 2021-08-24306.42 KB
Section 05: Study Procedures (Download) 2022-05-10457.18 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2021-08-24733.78 KB
Section 07: Clinical Considerations (Download) 2022-05-10633.91 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2022-05-10811.68 KB
Section 09: Counseling Considerations (Download) 2022-05-10214.55 KB
Section 10: Laboratory Considerations (Download) 2022-05-10687.23 KB
Section 11: Data Collection (Download) 2022-05-10484.51 KB
Section 12: Data Communiqués (Download) 2021-08-2478.19 KB
Section 12: Data Communiqué #1 (Download) 2020-02-0568.45 KB
Section 12: Data Communiqué #2 (Download) 2020-04-0961.54 KB
Section 12: Data Communiqué #3 (Download) 2020-10-2936.51 KB
Section 12: Data Communiqué #4 (Download) 2020-11-2530.03 KB
Section 12: Data Communiqué #5 (Download) 2021-01-2663.76 KB
Section 12: Data Communiqué #6 (Download) 2021-04-1854.99 KB
Section 12: Data Communiqué #7 (Download) 2021-12-21179.3 KB
Section 12: Data Communiqué #8 (Download) 2022-02-22179.39 KB
Section 12: Data Communiqué #9 (Download) 2022-04-05179.03 KB
Section 13: Study Reporting Plan (Download) 2022-05-10144.63 KB
Section 14: DELIVER Qualitative Component (Download) 2022-05-10663.69 KB
Training Slides
Protocol Version 2.0 and SSP v2.0 Updates (Download) 2021-08-261.71 MB