Corporate Compliance

Tip: Ensure your clinical trials process is compliant with these auditing steps

Healthcare Auditing Weekly, March 31, 2009

Before you conduct an audit of your facilities clinical trials/research studies billing, you need to define the overall scope, approach and time frame for the audit. Once you’ve done this, begin to outline how the individual audits will be conducted. A general process includes the following steps:

  • Collect and review existing policies and procedures and training materials
  • Interview selected staff to understand their interpretation of the current process being audited
  • Document the current understanding of the process based on the interviewees
  • Compare interviewee descriptions to the written policies and procedures
  • Conduct the audit
  • Analyze the data and results of the assessment
  • Draft the report
  • Provide the results to the responsible department heads and gather input
  • Finalize report and develop corrective action plan

This tip was adapted from The Healthcare Compliance Professional’s Guide to Clinical Trials. For more information about the book or to order your copy, visit the HCMarketplace.

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