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Regulatory Focus™ > News Articles > 7 > Real World Evidence: FDA Finalizes Guidance on Using EHRs in Clinical Studies

Real World Evidence: FDA Finalizes Guidance on Using EHRs in Clinical Studies

Posted 18 July 2018 | By Michael Mezher 

Real World Evidence: FDA Finalizes Guidance on Using EHRs in Clinical Studies

To advance the use of real world evidence in regulatory decision making, the US Food and Drug Administration (FDA) on Wednesday finalized its guidance detailing a policy for using electronic health record (EHR) data in FDA-regulated clinical investigations. 

According to FDA, conclusions drawn from data sourced from EHRs could be used to support the approval of new indications for already-approved drugs or to satisfy post-approval study requirements. 

"Every clinical use of a product produces data that can help better inform us about its safety and efficacy. This guidance issued today facilitates the use of electronic health record data in clinical investigations and helps integrate data collected in routine care settings into clinical trials," said Jacqueline Corrigan-Curay, director of the Office of Medical Policy at the Center for Drug Evaluation and Research. 

EHRs contain a wealth of information about a patient, such as diagnoses, pharmacy records, immunization history, test results and radiology images, which FDA says can be acceptable as evidence under the conditions laid out in the guidance. 

FDA says the guidance is meant to encourage the use of EHR data in clinical investigations and promote greater interoperability between EHR and electronic data capture (EDC) systems and it fulfills a requirement set by the 21st Century Cures Act to issue guidance on real world evidence in regulatory decision making. 


The guidance, which finalizes a draft version from 2016, provides recommendations to sponsors, clinical investigators, clinical research organizations (CROs), institutional review boards (IRBs) and other parties that may be interested in using EHR data in clinical investigations. 

The guidance clarifies a number of issues raised in comments to the public docket for the draft guidance, including what types of studies fall under the scope of the guidance; how to use interoperable or fully integrated EHR and electronic data capture (EDC) systems; recommendations for using certified or noncertified EHRs and information about how electronic source data principles apply to EHR data. 

The guidance also provides recommendations for inspection, recordkeeping and record retention requirements for EHRs used as source data for clinical investigations. FDA says its ability to accept data from EHRs as evidence will hinge on its ability to "verify the quality and integrity of the data" during inspections. 

One of the major challenges to using EHRs as a data source for regulatory purposes is the fact that many EHR systems are not interoperable, and do not adhere to specific data standards. 

To address this, FDA encourages drugmakers and clinical investigators to use EHR and EDC systems that are interoperable and recommends the use of systems that leverage existing open data standards. 

FDA also recommends the use of EHR systems that are certified by the Office of the National Coordinator for Health Information Technology (ONC) but provides advice for using EHR systems that are not ONC-certified. 

"EHR systems not certified by ONC, including EHR systems at foreign clinical sites, can provide adequate data to inform FDA’s regulatory decisions provided that adequate controls are in place to ensure the confidentiality, integrity, and security of data," FDA writes. 

FDAFederal Register Notice 

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