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비즈니스 · 2018. 7. 19.1 분 읽기
Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry; Availability
로컬 자동 번역 · 원본 출처 언어
요약
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 The guidance finalizes the draft guidance issued in May 2016.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →