Course Description

The FDA recognizes Electronic Health Records (EHRs) as data originators and in many cases, source documentation, which therefore subjects them to inspection. In its draft guidance for the Use of Electronic Health Record Data in Clinical Trials, the FDA expands upon prior guidance and provides its recommendations on the use of EHRs as source, and also outlines the responsibilities for ensuring quality and integrity of EHR data. As such, EHRs should be able to be obtained from multiple sources, they should be shareable, interoperable, and accessible to authorized parties. This web seminar will address recommendations for the use of EHRs as source data in clinical trials.

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Learning Objectives

• Describe the responsibilities and processes for assessing the validity, reliability, and integrity of EHR source data
• Review the FDA’s intentions to assess the compliance of EHRs with 21 CFR 11
• Evaluate best practices for using EHRs in clinical research
• Describe interoperability in EHR use
• Discuss the impact on recommendations for research conducted outside the U.S.

Who Should Attend

• Clinical Research Associates
• Project Managers
• Principal Investigators
• Clinical Research Coordinators
• Regulatory Affairs Professionals
• Academic Medical Center and Research Institution Professionals supporting clinical research
• Personnel responsible for ensuring compliance with GCP regulations

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.