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Training Version
Table of Contents - Current Sections (Download) 2018-09-07235.1 KB
Section 01: Introduction (Download) 2018-09-07147.91 KB
Section 02: Documentation Requirements (Download) 2018-09-07214.11 KB
Section 03: Informed Consent (Download) 2018-09-07473.24 KB
Section 04: Procedural Considerations (Download) 2018-09-07428.73 KB
Section 05: Study Product Considerations (For Non-Pharmacy Staff) (Download) 2018-09-07507.96 KB
Section 06: Clinical Considerations (Download) 2018-09-07353.92 KB
Section 07: Adverse Event Reporting and Safety Monitoring (Download) 2018-09-07551.23 KB
Section 08: Laboratory Considerations (Download) 2018-09-07372.83 KB
Section 09: Counseling Considerations (Download) 2018-09-07220.33 KB
Section 10: Behavioral Measures (Download) 2018-09-07633.15 KB
Section 11: Data Collection (Download) 2018-09-07811 KB
Section 12: Data Communiqués (Download) 2018-09-07103.94 KB
Section 13: Study Reporting Plan (Download) 2018-09-07277.53 KB