This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. For the purposes of this guidance, EHRs are electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions. For example, a typical EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results. EHRs can be used by health care institutions to integrate real-time electronic health care information from medical devices and different health care providers involved in the care of patients. This guidance uses a broad definition for EHRs in an attempt to be inclusive of many different types of EHRs.
This guidance provides recommendations on:
- Deciding whether and how to use EHRs as a source of data in clinical investigations
- Using EHRs that are interoperable with electronic systems3 supporting clinical investigations
- Ensuring the quality and the integrity of EHR data that are 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, recordkeeping, and record retention requirements
In an effort to modernize and streamline clinical investigations, the goals of this guidance are as follows:
- Facilitate the use of EHR data in clinical investigations
- Promote the interoperability of EHRs and electronic systems supporting the clinical investigation
This guidance expands upon recommendations found in the following guidances for industry as they relate to electronic source data from EHRs that are owned and managed by health care organizations:
- Computerized Systems Used in Clinical Investigations
- Electronic Source Data in Clinical Investigations