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Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2019-01-04833.76 KB
Table of Contents - Current Sections (Download) 2019-01-0466.56 KB
Section 01: Introduction (Download) 2019-01-14363.05 KB
Section 02: Documentation Requirements (Download) 2019-01-04252.29 KB
Section 03: Participant Accrual and Retention (Download) 2019-01-04406.87 KB
Section 04: Informed Assent and Consent (Download) 2019-01-04682.87 KB
Section 05: Study Procedures (Download) 2019-01-04568.01 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2019-01-04583.71 KB
Section 07: Clinical Considerations (Download) 2019-01-04683.03 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2019-01-04782.2 KB
Section 09: Laboratory Considerations (Download) 2019-01-041.22 MB
Section 10: Counseling Procedures (Download) 2019-01-04496.51 KB
Section 11: Behavioral Assessments (Download) 2019-01-041.11 MB
Section 12: Data Collection (Download) 2019-01-04980.65 KB
Section 13: Data Communiqués (Download) 2019-01-04132.51 KB
Section 13: Data Communiqués #1 (Download) 2018-11-01103.64 KB
Section 13: Data Communiqués #2 (Download) 2019-03-13115.04 KB
Section 13: Data Communiqués #3 (Download) 2019-05-23159.57 KB
Section 14: Study Reporting Plan (Download) 2019-01-04517.4 KB