that the structured data elements obtained from the EHR correspond with the protocol-defined
data collection plan (e.g., time and method of measurement). In addition, for extraction of
unstructured data, sponsors should consider the reliability and quality of unstructured EHR data
and the appropriateness of using it as critical source data, such as study endpoints.
C. Validation
Sponsors should ensure that the interoperability of EHR and EDC systems (e.g., involving the
automated electronic transmission of relevant EHR data to the EDC system) functions in the
manner intended in a consistent and repeatable fashion and that the data are transmitted
accurately, consistently, and completely. The sponsor’s quality management plan (e.g., standard
operating procedures, software development life cycle model, change control procedures) should
address the interoperability of the EHR and EDC system and the automated electronic
transmission of EHR data elements to the EDC system. Sponsors should ensure that software
updates to the sponsor’s EDC systems do not affect the integrity and security of EHR data
transmitted to the sponsor’s EDC systems. In addition, as part of the quality management plan,
FDA encourages sponsors to periodically check a subset of the extracted data for accuracy,
consistency, and completeness with the EHR source data and make appropriate changes to the
interoperable system when problems with the automated data transfer are identified.
D. Data From Multiple EHR Systems
The EHR system at the clinical investigation site may be interoperable with multiple EHR
systems from many different health care organizations or institutions that are not affiliated with
the clinical investigation site. If data from multiple EHR systems from different health care
organizations and institutions are integrated with EHR data at the clinical investigation site, data
from another institution’s EHR system may be used and transmitted to the sponsor’s EDC
system provided that data sharing agreements are in place.
V. BEST PRACTICES FOR USING EHRs IN CLINICAL INVESTIGATIONS
The use of EHRs as a source of data in clinical investigations may involve additional
considerations, planning, and management as described in this section. Sponsors and clinical
investigators should ensure that policies and processes for the use of EHRs at the clinical
investigation site are in place and that there are appropriate security measures employed to
protect the confidentiality and integrity of the study data.
Sponsors should also ensure that study monitors have suitable access to all relevant subject
information pertaining to a clinical investigation, as appropriate. Such access must be described
in the informed consent (see 21 CFR 50.25(a)(5)) (see section V.E). Furthermore, at any time
during the course of a clinical investigation, sponsors should discuss with the relevant FDA
review division any unique issues or challenges encountered relating to the data collection from
the EHRs (see, e.g., 21 CFR 312.41).