MTN-030/IPM 041 Study Specific Procedures Manual (SSPs)

DescriptionDateSize
Individual Sections
Overview of Section Contents (Download) 2017-03-24204.27 KB
Section 01: Introduction (Download) 2017-03-24220.94 KB
Section 02: Documentation Requirements (Download) 2017-03-24254.25 KB
Section 03: Accrual and Retention (Download) 2017-03-24240.85 KB
Section 04: Informed Consent (Download) 2017-03-24412.69 KB
Section 05: Study Procedures (Download) 2017-03-24329.01 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2017-03-24513.64 KB
Section 07: Clinical Considerations (Download) 2017-03-24403.44 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2017-03-24273.69 KB
Section 09: Laboratory Considerations (Download) 2017-03-24614.09 KB
Section 10: Counseling Procedures (Download) 2017-03-24227.39 KB
Section 11: Data Collection (Download) 2017-03-24141.45 KB
Section 12: Data Communiqués (Download) 2017-03-2474.89 KB
Section 12: Data Communiqué #1 (Download) 2017-07-1427.96 KB
Section 13: Study Reporting Plan (Download) 2017-03-2490.85 KB

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