Back to top
DescriptionDateSize
Individual Sections
Overview and Control Document – Version History and Notice of Changes (Download) 2021-05-171.05 MB
Table of Contents - Current Sections (Download) 2021-05-17111.8 KB
Section 01: Introduction (Download) 2021-05-17188.85 KB
Section 02: Documentation Requirements (Download) 2021-05-17231.82 KB
Section 03: Participant Accrual and Retention (Download) 2021-05-17198.77 KB
Section 04: Informed Consent (Download) 2021-05-17306.42 KB
Section 05: Study Procedures (Download) 2021-05-17567.05 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2020-04-09689.44 KB
Section 07: Clinical Considerations (Download) 2021-05-17790.92 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2021-05-17917.15 KB
Section 09: Counseling Considerations (Download) 2020-04-09289.5 KB
Section 10: Laboratory Considerations (Download) 2021-02-01830.49 KB
Section 11: Data Collection (Download) 2021-05-17609.59 KB
Section 12: Data Communiqués (Download) 2019-12-19133 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 13: Study Reporting Plan (Download) 2021-05-17207.17 KB
Section 14: DELIVER Qualitative Component (Download) 2020-04-09673.05 KB