The UK’s medicines regulator, the MHRA, warned that inadequate electronic health record systems are costing hospitals clinical trial competitiveness. In guidance on eHR compliance with GCP requirements, the agency said noncompliant systems could lead commercial sponsors to reject sites during selection, and could also affect marketing authorization applications or publications if trial data cannot be reconstructed. The MHRA’s compliance emphasis includes audit trails and requirements around investigators’ ability to demonstrate medical oversight when eHRs are used. The message is aimed at reducing trial delays and supporting patient recruitment. For biotech sponsors, the guidance increases the operational burden of assessing site readiness and strengthens the case for earlier eHR compliance diligence as part of global clinical planning.
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