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DescriptionDateSize
Training Version
Section 01: Introduction (Download) 2020-01-31314.35 KB
Section 02: Documentation Requirements (Download) 2020-01-31374.13 KB
Section 03: Participant Accrual and Retention (Download) 2020-01-31338.42 KB
Section 04: Informed Consent (Download) 2020-01-31489.82 KB
Section 05: Study Procedures (Download) 2020-01-31682.67 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2020-01-31591.73 KB
Section 07: Clinical Considerations (Download) 2020-01-31969.57 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2020-01-31961.24 KB
Section 09: Counseling Considerations (Download) 2020-01-31449.97 KB
Section 10: Laboratory Considerations (Download) 2020-01-311.18 MB
Section 11: Data Collection (Download) 2020-01-31814.64 KB
Section 12: Data Communiqués (Download) 2020-01-31156.84 KB
Section 13: Study Reporting Plan (Download) 2020-01-31303.89 KB
Section 14: B-PROTECTED Qualitative Component (Download) 2020-01-31925.38 KB