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Entreprise · 19/07/20181 min de lecture
Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry; Availability
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Résumé
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Use of Electronic Health Record Data in Clinical Investigations." The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance finalizes the draft guidance issued in May 2016.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →