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FDA Urges Drug Sponsors to Ensure Data is ‘Interoperable or Integrated’
Drugs Regulatory Affairs
Drug sponsors and investigators should work with organizations that offer either interoperable or integrated electronic health records or electronic data capture systems, the FDA said in a final guidance released Wednesday.
The guidance seeks to clarify ways that electronic health records can help make clinical trials go more smoothly and also help in the evaluation of data from foreign trials.
The agency urged sponsors to use EHR or EDC systems so the relevant information “may be entered once at the point-of-care and used many times without manual re-entry or manual source data verification.”