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

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...