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FDA Released New Guidance to Use Electronic Health Records (EHR) in Clinical Investigations: Impact for RBM

By Penny Manasco - August 7, 2018

 The FDA Guidance on using EHR in clinical investigations, released in July, provides recommendations on the following: 
  • “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, record-keeping, and record retention requirements”
Consider this required reading for everyone involved in clinical trials.  All trials should move to electronic source, based on the new ICHE6(R2) guidance on source data, which must meet the requirements for ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate). While the FDA will not require that EHRs meet 21 CFR Part 11, it does want to ensure that EHR data cannot be changed and the data are attributable to an individual with an audit trail.

There is additional information about selecting an Electronic Health Record.  The FDA encourages that EHR systems be certified through the Office of the National Coordinator for Health Information Technology at the Department of Health and Human Services (ONC) Health IT Certification process and that they use the ONC’s interoperability standards.  This is not a requirement and systems that do not have the certification should meet guidelines assuring confidentiality and integrity of data, have policies and processes for the use of the EHR system, limit access to authorized users, identify the data author and have audit trails available to track changes to data, and have records available for inspection. 

In addition, the guidance also recommends periodically checking a subset of the extracted data for accuracy, consistency, and completeness with the EHR source data.

eSource Principles
The FDA recommends documenting the primary source for data imported directly from the EHR system  be listed as the EHR system. In addition, data management documentation should include the manufacturer, model number, and version number of the EHR system and whether ONC certified the EHR system.

Sponsors should ensure monitors have adequate  access to all relevant subject information; this point was specifically mentioned in the Guidance.

EHR source data and the documentation associated with the EHR data and processes should be available to Inspectors.  They can be viewable within the EHR or as certified copies

RBM Impact:
This Guidance reaffirms the FDA’s expectation that data will be available for remote review as part of Risk Based Monitoring and quality oversight.  The FDA has provided an option that can eliminate transcription and provide data directly into the EDC.  There are many complexities to this process, particularly for multi-center trials with multiple EHRs, but we are moving in the right direction.
The link to the guidance is: