For the purposes of this guidance, electronic systems used in the provision of medical care (e.g.,
electronic health records (EHRs)) generally are systems that are (1) designed for medical care of
patients not enrolled in a clinical investigation and (2) owned and managed by the institutions
providing medical care. These electronic systems may produce additional electronic records
during the course of patients’ care (e.g., hospital admission records, electronic health records,
pharmacy records, laboratory records, imaging records, electronic consultation records) that may
be useful for providing data in clinical investigations. As provided in the guidance for industry
Electronic Source Data in Clinical Investigations, FDA does not intend to assess compliance of
these systems with part 11.24 For more information on best practices for using data from EHRs
in FDA-regulated clinical investigations, see the draft guidance for industry Use of Electronic
Health Records Data in Clinical Investigations.”25
