Back to top
DescriptionDateSize
Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2019-07-011.1 MB
Table of Contents - Current Sections (Download) 2019-07-01162.65 KB
Section 01: Introduction (Download) 2019-07-01184.29 KB
Section 02: Documentation Requirements (Download) 2019-07-01211.73 KB
Section 03: Participant Accrual and Retention (Download) 2019-07-01206.4 KB
Section 04: Informed Assent and Consent (Download) 2019-07-01318.43 KB
Section 05: Study Procedures (Download) 2019-07-01376.65 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2019-07-01406.98 KB
Section 07: Clinical Considerations (Download) 2019-07-01366.89 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2019-07-01489.36 KB
Section 09: Laboratory Considerations (Download) 2019-07-01835.39 KB
Section 10: Counseling Procedures (Download) 2019-07-01312.54 KB
Section 11: Behavioral Assessments (Download) 2019-07-01783.72 KB
Section 12: Data Collection (Download) 2019-07-01525.01 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) 2019-07-01224.18 KB