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Imprese · 17/05/20161 min di lettura
Use of Electronic Health Record Data in Clinical Investigations; Draft Guidance for Industry; Availability
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Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Electronic Health Record Data in Clinical Investigations." The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →