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Individual Sections
Table of Contents - Current Sections (Download) 2020-04-30214.8 KB
Overview and Control Document – Version History and Notice of Changes (Download) 2020-04-301.02 MB
Section 01: Introduction (Download) 2020-04-30302.11 KB
Section 02: Documentation Requirements (Download) 2020-04-30322.04 KB
Section 03: Participant Accrual and Retention (Download) 2020-04-30291.49 KB
Section 04: Informed Consent (Download) 2020-04-30458 KB
Section 05: Study Procedures (Download) 2020-04-30651.2 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2020-04-30544.52 KB
Section 07: Clinical Considerations (Download) 2020-04-30894.29 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2020-04-30908.02 KB
Section 09: Counseling Considerations (Download) 2020-04-30400.88 KB
Section 10: Laboratory Considerations (Download) 2020-04-301.18 MB
Section 11: Data Collection (Download) 2020-04-30772.63 KB
Section 12: Data Communiqués (Download) 2020-04-30153.66 KB
Section 13: Study Reporting Plan (Download) 2020-04-30312.03 KB
Section 14: B-PROTECTED Qualitative Component (Download) 2020-04-30851.7 KB