The guidance recommendations cover four main areas: Whether and how to use EHRs as a source of data, using EHRs that are interoperable with electronic systems supporting clinical investigations, ensuring the quality and integrity of EHR data used, and ensuring the EHR data collected and used meets FDA requirements.
Using EHRs in clinical trials can help modernize and streamline such investigations, according to the guidance.
The guidance is still in draft form, and the FDA seeks comments and suggestions on the document. To read the guidance, click here.
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