Electronic health records (EHRs) are a promising source of data for clinical trials, US FDA says, but study sponsors can't be lax about document control when relying on hospital-owned patient-record systems.
The agency issued guidance July 18 to describe important considerations for using EHRs to collect real-world data to support FDA approvals of devices, drugs and biologics. It finalizes a May 2016 draft version, sticking mostly with the proposals in the earlier document, but adding some clarifications and tweaks
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