FDA Releases Guidance Document for Use of EHRs in Clinical Investigations

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Guidelines Outline Integration of Systems, Best Practices

Last month, the U.S. Food and Drug Administration (FDA) released a document outlining their industry guidance tips for optimal use of EHRs within clinical investigations.

The guidance document, intended to aid sponsors, clinical investigators, and others in the use of electronic health record data, was a collaborative effort between several agencies, including the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS).

The guidance provides recommendations on:

  • Deciding whether and how to use EHRs as a source of data in clinical investigations
  • Using EHR systems that are interoperable with electronic data capture (EDC) systems in clinical investigations
  • Ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical investigations
  • Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements

The FDA clarified that the guidelines are not binding, rather, they represent the Administration’s ‘current thinking’ on the matter. Users were encouraged to utilize an alternative approach if that approach satisfies the appropriate requirements.

The full document is available on the FDA’s website.

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Rob Senior
Rob Senior

Rob has 15 years of experience writing and editing for healthcare. He previously worked for ADVANCE from 2002 to 2012.

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