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Pharmaceuticals, Medical Devices

Clinical Trial Audits and Consequences of Non-Compliance

About the Course

Sponsors can put measures in place in an attempt to dissuade researchers from being non-compliant, but those measures are only as effective as the personnel applying them. This eLearning course will provide a description of the clinical trial audit process and how audits help to ensure trials are conducted in accordance with regulatory requirements. Actions that can be taken if investigators are not compliant will also be discussed. This online training course will provide you with some tools for conducting effective clinical trial audits. After completing this training, you will be able to identify FDA standards for conducting and reporting clinical site inspections, as well as recognize FDA’s system for classifying inspections and taking corrective action.