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DescriptionDateSize
Final Case Report Forms
MTN-023/IPM 030 Final Case Report Forms (Download) 2014-02-19643.03 KB
SSP Manual - All Sections Combined
MTN-023/IPM 030 SSP Manual (Download) 2016-02-235.07 MB
SSP Manual - Individual Sections
Overview of Section Contents (Download) 2016-02-23193.26 KB
Section 01: Introduction (Download) 2016-02-23289.65 KB
Section 02: Documentation Requirements (Download) 2015-02-25449.8 KB
Section 03: Participant Accrual and Retention (Download) 2015-02-25354.13 KB
Section 04: Informed Assent and Consent (Download) 2015-09-0261.27 KB
Section 05: Study Procedures (Download) 2016-02-23432.15 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2015-04-07693.24 KB
Section 07: Clinical Considerations (Download) 2015-09-02206.58 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2015-02-25422.25 KB
Section 09: Counseling Procedures (Download) 2015-02-25327.32 KB
Section 10: Laboratory Considerations (Download) 2015-04-07903.31 KB
Section 11: Data Collection (Download) 2016-02-01582.99 KB
Section 12: Data Communiqués (Download) 2015-02-2590.46 KB
Section 12: Data Communiqués #1 (Download) 2014-06-24416.25 KB
Section 12: Data Communiqués #2 (Download) 2015-03-02337 KB
Section 12: Data Communiqués #3 (Download) 2015-04-0674.37 KB
Section 12: Data Communiqués #4 (Download) 2015-10-0249.28 KB
Section 13: Study Reporting Plan (Download) 2016-02-01218.77 KB
Section 14: Behavioral Measures (Download) 2016-02-23427.12 KB