Guidance

Clinical trials: how NHS trusts and health boards can maintain compliant electronic health record systems

Guidance for NHS trusts carrying out clinical trials and organisations sponsoring a trial to ensure electronic health record systems are compliant.

Documents

MHRA's position statement and guidance on electronic health records

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Details

NHS trusts and health boards sponsoring a clinical trial, or hosting a trial sponsored by a commercial company need to ensure their electronic health record systems comply with legal requirements for good clinical practice.

This guidance covers common inspection findings related to electronic health record systems and expectations on the design, build and implementation of an electronic health record system.

Published 22 October 2015