Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations – December 6, 2018

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Thursday, December 6, 2018
1:00pm - 2:00pm (Eastern)

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation.  The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

Issuing the guidance for industry on the use of electronic heath record (EHR) data in clinical investigations is part of the agency’s commitment to furthering the advancement and usage of new technologies in scientific and regulatory processes. The goals of the guidance are to:

  • Modernize and streamline clinical investigations.
  • Promote the interoperability of EHR and EDC systems by encouraging sponsors and health care organizations to work with EHR and electronic data capture (EDC) vendors to further advance the interoperability and integration of EHRs and EDC systems.

This webinar will provide insight on FDA’s recommendations on the use of EHR data in FDA-regulated clinical investigations.


  • Hear directly from the FDA experts on using EHR data in clinical investigations
  • Take a deep dive into the recommendations presented in the final guidance document


  • Regulatory affairs professionals
  • Researchers
  • Clinical investigators
  • Sponsors
  • CROs
  • IRBs
  • Foreign regulators
  • Consultants
  • Clinical research coordinators
  • EHR and EDC technology vendors
  • Other stakeholders interested in using EHR data in clinical investigations


For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

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