FDA Guidance: Use of Electronic Health Record Data in Clinical Investigations, 7/18
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In July, 2018, the CDER, CBER and CDRH branches of the FDA published Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations. This document is intended to assist study sponsors, clinical investigators, contract research organizations, and institutional review boards (IRBs), in the use of electronic health record (EHR) data in FDA-regulated clinical investigations.
EHR data can include an individual’s medical history, diagnoses, treatment plans, allergies, immunizations radiology images, pharmacy records, lab and test results.
This guidance identifies best practices including:
- Limiting access to authorized individuals
- Identification of record authors
- Audit trails to track changes
- Retention of records
- Record availability for FDA inspections
- Data privacy and security
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