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 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.

Topics include:
      ·          Clinical Trial Audit
      ·          The Audit Process
      ·          FDA Inspection
      ·          Non-compliance