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Individual Sections
Overview and Version Control (Download) 2012-05-21227.63 KB
Table of Contents (Download) 2011-09-14116.28 KB
Section 01: Introduction (Download) 2011-09-02101.2 KB
Section 02: Protocol (Download) 2011-12-1965.94 KB
Section 03: Documentation Requirements (Download) 2011-09-02218.69 KB
Section 04: Participant Accrual (Download) 2011-12-19401.15 KB
Section 05: Informed Consent (Download) 2012-01-1399.09 KB
Section 06: Participant Follow-up (Download) 2012-05-21560.55 KB
Section 07: Visit Checklists (Download) 2011-12-19141.95 KB
Section 08: Participant Retention (Download) 2011-09-02129.37 KB
Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) 2011-09-021.96 MB
Section 10: Clinical Considerations (Download) 2012-04-13635.85 KB
Section 11: Adverse Event Reporting and Safety Monitoring (Download) 2011-11-04295.61 KB
Section 12: Laboratory Considerations (Download) 2012-04-131.17 MB
Section 13: Data Collection (Download) 2011-09-14942.24 KB
Section 14: Data Communiques (Download) 2011-09-0252.46 KB
Section 14: Data Communiques #1 (Download) 2011-09-1521.87 KB
Section 14: Data Communiques #2 (Download) 2011-12-1456.29 KB
Section 14: Data Communiques #3 (Download) 2011-12-1940.13 KB
Section 14: Data Communiques #4 (Download) 2012-02-1524.83 KB
Section 14: Data Communiques #5 (Download) 2012-04-2720.42 KB
Section 14: Data Communiques #6 (Download) 2012-05-2325.64 KB
Section 15: Study Reporting Plan (Download) 2011-09-0274.03 KB
Section 16: Behavioral Measures: CASI Questionnaires and the Semi-Structured Interview (SSI) (Download) 2012-03-21810.41 KB
Section 17: Counseling Considerations (Download) 2011-12-19230.31 KB