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Individual Sections
Overview and Version Control (Download) 2012-03-0585.82 KB
Section 01: Introduction (Download) 2011-04-2581.89 KB
Section 02: Protocol (Download) 2011-04-25591.27 KB
Section 03: Documentation Requirements (Download) 2011-04-25164.34 KB
Section 04: Participant Accrual (Download) 2011-04-25375.15 KB
Section 05: Informed Consent (Download) 2011-04-25254.13 KB
Section 06: Participant Follow-up (Download) 2012-03-05411.85 KB
Section 07: Visit Checklists (Download) 2011-04-2559.44 KB
Section 08: Participant Retention (Download) 2011-04-2597.71 KB
Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) 2011-04-25322 KB
Section 10: Clinical Considerations (Download) 2011-04-25227.46 KB
Section 11: Adverse Event Reporting and Safety Monitoring (Download) 2011-04-25245.14 KB
Section 12: Laboratory Considerations (Download) 2011-12-28449.45 KB
Section 13: Data Collection (Download) 2011-12-01738.66 KB
Section 14: Counseling Considerations (Download) 2011-04-25135.96 KB
Section 15: Data Communiqué (Download) 2011-04-2510.45 KB
Section 15: Data Communiqué #1 (Download) 2011-07-0820.83 KB
Section 15: Data Communiqué #2 (Download) 2011-11-1520.64 KB
Section 15: Data Communiqué #3 (Download) 2012-02-0923.64 KB
Section 16: ACASI Users’ Manual (Download) 2011-04-251.61 MB
Section 17: Study Reporting Plan (Download) 2011-04-2523.61 KB