Monitoring and Reporting Safety

This module defines adverse event and serious adverse events. It provides specific guidance for documenting an event correctly. This module provides regulatory guidance for determining if an event is reportable under 45 CFR Part 46. In addition, it discusses what, when, and how to report events to the FDA, sponsor, funding agency, ClinicalTrials.gov, and the DUHS IRB.

Duration: < 1 hour

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Free