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Data Control Key In Applying Electronic Health Records As Clinical Trial Tool, FDA Says

 
• By David Filmore

Newly finalized guidance from US FDA details the agency's considerations for device and drug sponsors to rely on electronic health records as a clinical trial data source.

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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• By Natasha Barrow

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• By Natasha Barrow

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• By Marion Webb

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