Adverse Event Monitoring for CRAs

During monitoring visits one of the most important and impacting activities that a CRA performs is the source document verification of Adverse Events. The CRA is the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of adverse events can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety regulatory and ICH definitions will be reviewed and applied to the monitoring process. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

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