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Training Version
Table of Contents - Current Sections (Download) 2018-08-1066.46 KB
Section 01: Introduction (Download) 2018-08-10361.81 KB
Section 02: Documentation Requirements (Download) 2018-08-10253.87 KB
Section 03: Participant Accrual and Retention (Download) 2018-08-10406.64 KB
Section 04: Informed Assent and Consent (Download) 2018-08-10661.8 KB
Section 05: Study Procedures (Download) 2018-08-10569.57 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2018-08-10583.84 KB
Section 07: Clinical Considerations (Download) 2018-08-10693.61 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2018-08-10772.84 KB
Section 09: Laboratory Considerations (Download) 2018-08-101.22 MB
Section 10: Counseling Procedures (Download) 2018-08-10490.91 KB
Section 11: Behavioral Assessments (Download) 2018-08-101.1 MB
Section 12: Data Collection (Download) 2018-08-10974.13 KB
Section 13: Data Communiqués (Download) 2018-08-10132.33 KB
Section 14: Study Reporting Plan (Download) 2018-08-10517.54 KB