임상시험센터 임상정보팀...
TRANSCRIPT
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2014-07-21 임상시험센터 임상정보팀 김윤남 1
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국제 임상데이터 교환 표준 컨소시엄
Clinical Data Interchange Standards Consortium
데이터 데이터 데이터….
모두 데이터에 대한 이야기
임상시험분야 표준개발기구
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Why Data Standards? What Can Standards Do for Us?
many different connotations
various stages of the clinical research process
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Why Data Standards? What Can Standards Do for Us?
many different connotations
various stages of the clinical research process
common research business processes
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common regulatory guidelines
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Why Data Standards? What Can Standards Do for Us?
time and cost while improving quality
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…
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common
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CDISC Standards for medical research and its link with healthcare vendor-neutral, platform-independent and freely available via the CDISC website
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Standards
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Protocol
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Study Data Tabulation Model (SDTM)
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ODM (Operational Data Model)
데이터 관리 시스템간의 데이터에 대한 저장, 교환을 위해
포맷 혹은 임상 시험과 연관된 스터디 데이터, 스터디 메타데이터
혹은 관리적 데이터 보관을 위해
사용되는 vendor-independent한 형식의 데이터 모델
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CDISC Standards
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CDISC in eCTD Submission
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시스템 마련 CDISC 검증시스템 eCTD 접수, 관리 시스템
우리가
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국내? 임상시험자료 표준형식(CDISC)
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Thank you