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Individual Sections
Overview of Section Contents (Download) 2016-10-10182.62 KB
Section 01: Introduction (Download) 2016-02-17223.94 KB
Section 02: Documentation Requirements (Download) 2015-11-25422.66 KB
Section 03: Accrual and Retention (Download) 2015-11-25293.15 KB
Section 04: Informed Consent (Download) 2015-11-25315.85 KB
Section 05: Study Procedures (Download) 2015-11-25454.62 KB
Section 06: MTN-029/IPM 039 Study Product Considerations for Non-Pharmacy Staff (Download) 2015-11-25415.93 KB
Section 07: Clinical Considerations (Download) 2015-11-25308.26 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2015-11-25417.24 KB
Section 09: Laboratory Considerations (Download) 2016-10-10804.77 KB
Section 10: Counseling Procedures (Download) 2016-02-17300.1 KB
Section 11: Data Collection (Download) 2015-11-25371.32 KB
Section 12: Data Communiqués (Download) 2015-11-2510.36 KB
Section 12: Data Communiqué #1 (Download) 2016-03-2118.84 KB
Section 12: Data Communiqué #2 (Download) 2016-04-2827.76 KB
Section 13: Study Reporting Plan (Download) 2015-11-2561.09 KB