New FDA’s draft guidance: Electronic Health Record Data in Clinical Investigations

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New FDA’s draft guidance: Electronic Health Record Data in Clinical Investigations

FDA has published a new draft guidance on Electronic Health Record Data to support the parties, likes sponsors, clinical investigators, contract research organizations and institutional review boards, which are interested on FDA- regulated clinical investigations.

The aim of this guidance is to outline which quality and integrity requirements the EHR data have to meet in order to be compliant during FDA’s on-site inspections and audits.

This draft helps to clarifies FDA’S expectations when EHRs are used as a source of data in clinical investigations of human drugs, biological products and medical devices.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf