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Individual Sections
Overview of Section Contents (Download) 2018-04-13378.01 KB
Section 01: Introduction (Download) 2018-04-13489.82 KB
Section 02: Documentation Requirements (Download) 2017-11-20371.95 KB
Section 03: Accrual and Retention (Download) 2017-09-11332.71 KB
Section 04: Informed Consent (Download) 2017-09-11430.52 KB
Section 05: Study Procedures (Download) 2018-04-13494.73 KB
Section 06: Study Product Considerations for Non- Pharmacy Staff (Download) 2017-09-11766.68 KB
Section 07: Clinical Considerations (Download) 2017-11-20827.31 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2017-09-11522.77 KB
Section 09: Laboratory Considerations (Download) 2017-12-11494.98 KB
Section 10: Counseling Considerations (Download) 2017-09-11420.44 KB
Section 11: Behavioral Measures (Download) 2018-04-13847.37 KB
Section 12: Data Collection (Download) 2018-04-13556.87 KB
Section 13: Data Communiqués (Download) 2017-09-11264 KB
Section 13: Data Communiqué #1 (Download) 2018-01-2933.45 KB
Section 13: Data Communiqué #2 (Download) 2018-04-1362.82 KB
Section 14: Study Reporting Plan (Download) 2017-09-11207.29 KB