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Individual Sections
Overview and Control Document – Version History and Notice of Changes (Download) 2019-11-151.1 MB
Table of Contents (Download) 2019-11-15221.46 KB
Section 01: Introduction (Download) 2019-11-15196.5 KB
Section 02: Documentation Requirements (Download) 2019-11-15211.7 KB
Section 03: Accrual and Retention (Download) 2019-11-15142.96 KB
Section 04: Informed Consent (Download) 2019-11-15167.24 KB
Section 05: Study Procedures (Download) 2019-11-15262.69 KB
Section 06: Counseling Considerations (Download) 2019-11-15212.78 KB
Section 07: Behavioral Measures (Download) 2019-11-15257.99 KB
Section 08: Study Product Considerations for Non-Pharmacy Staff (Download) 2019-11-15392.59 KB
Section 09: Clinical Considerations (Download) 2019-11-15294.78 KB
Section 10: Adverse Event Reporting and Safety Monitoring (Download) 2019-11-15352.65 KB
Section 11: Laboratory Considerations (Download) 2019-11-15330.48 KB
Section 12: Data Collection (Download) 2019-11-15472.12 KB
Section 13: Data Communiqués (Download) 2019-11-1579.83 KB
Section 14: Study Reporting Plan (Download) 2019-11-15166.41 KB