Clinical Trial Audits and Consequences of Non-Compliance
Sponsors can put measures in place in an attempt to dissuade researchers from being noncompliant, but those measures are only as effective as the personnel applying them. This 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. Topics in this course include: Clinical Trial Audit, FDA Inspection, and Noncompliance. After completing this course, learners 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.
Identify the differences between a sponsor site audit and an FDA inspection. Recognize FDA standards for conducting and reporting clinical site inspections. Identify FDA’s system for taking corrective actions.