Adverse Event Monitoring for CRAs Trailer

During monitoring visits, one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA serves as the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post-marketing labeling. This includes causality, expectedness/unanticipated, and other important concepts. 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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