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Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2018-10-05542.1 KB
Table of Contents - Current Sections (Download) 2018-10-05373.12 KB
Section 01: Introduction (Download) 2018-10-05258.7 KB
Section 02: Documentation Requirements (Download) 2018-10-05418.05 KB
Section 03: Accrual and Retention (Download) 2018-10-05214.31 KB
Section 04: Informed Consent (Download) 2018-10-05439.35 KB
Section 05: Study Procedures (Download) 2018-10-05454.07 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2018-10-05764.06 KB
Section 07: Behavioral Measures (Download) 2018-10-05534.35 KB
Section 08: Clinical Considerations (Download) 2018-10-05784.42 KB
Section 09: Adverse Event Reporting and Safety Monitoring (Download) 2018-10-05608.17 KB
Section 10: Laboratory Considerations (Download) 2018-10-05823.41 KB
Section 11: Counseling Procedures (Download) 2018-10-05344.23 KB
Section 12: Data Collection (Download) 2018-10-05959.78 KB
Section 13: Data Communiqués (Download) 2018-10-05268.59 KB
Section 13: Data Communiqué #1 (Download) 2018-06-2727.78 KB
Section 13: Data Communiqué #2 (Download) 2018-08-3139.56 KB
Section 13: Data Communiqué #3 (Download) 2018-11-13155.76 KB
Section 14: Study Reporting Plan (Download) 2018-10-05401.92 KB