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DescriptionDateSize
Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2019-03-19761.45 KB
Table of Contents - Current Sections (Download) 2018-12-20372.21 KB
Section 01: Introduction (Download) 2019-03-19159.33 KB
Section 02: Documentation Requirements (Download) 2018-12-20394.08 KB
Section 03: Accrual and Retention (Download) 2018-11-09506.89 KB
Section 04: Informed Consent (Download) 2018-11-09516.08 KB
Section 05: Study Procedures (Download) 2018-11-09698.1 KB
Section 06: Behavioral Measures (Download) 2018-12-201 MB
Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) 2018-11-09766.87 KB
Section 08: Clinical Considerations (Download) 2018-12-20653.64 KB
Section 09: Adverse Event Reporting and Safety Monitoring (Download) 2018-12-20701.88 KB
Section 10: Laboratory Considerations (Download) 2019-03-19787.2 KB
Section 11: Counseling Procedures (Download) 2018-11-09424.9 KB
Section 12: Data Collection (Download) 2018-12-20628.34 KB
Section 13: Data Communiqués (Download) 2018-11-09209.64 KB
Section 14: Study Reporting Plan (Download) 2018-11-09572.2 KB