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DescriptionDateSize
Training Version
Overview of Section Contents (Download) 2017-07-14243.32 KB
Section 01: Introduction (Download) 2017-07-14216.3 KB
Section 02: Documentation Requirements (Download) 2017-07-14314.28 KB
Section 03: Participant Accrual and Retention (Download) 2017-07-14349.76 KB
Section 04: Informed Assent and Consent (Download) 2017-07-14563.08 KB
Section 05: Study Procedures (Download) 2017-07-14633.49 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2017-07-14561.57 KB
Section 07: Clinical Considerations (Download) 2017-07-14482.49 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2017-07-14746.05 KB
Section 09: Laboratory Considerations (Download) 2017-07-141.1 MB
Section 10: Counseling Procedures (Download) 2017-07-14375.79 KB
Section 11: Behavioral Assessments (Download) 2017-07-14726.47 KB
Section 13: Data Communiqués (Download) 2017-07-14133.98 KB