The presentation refers to electronic systems used to create, modify, maintain, archive, retrieve, or transmit an electronic record required for FDA regulated clinical investigations.
Regarding EHR, the draft guidance indicates that, “electronic systems used in the provision of medical care (e.g., electronic health records (EHRs)) generally are systems that are (1) designed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. FDA does not intend to assess compliance of these systems
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11.24 For more information on best practices for using data from EHRs in FDA-regulated clinical investigations, see the draft guidance for industry “Use of Electronic Health Records Data in Clinical Investigations.”
