Implementing CDISC Using SAS: An End-to-End Guide, Revised Second Edition (Korean edition) (Paperback, 2)


저자:Jack Shostak,Chris Holland
번역가:대구가톨릭대학교 신임희 박사, 곽상규 박사, 클루피 김기환 대표이사, 조동훈 박사, 전보름 연구원, 강은지 연구원
가격:₩ 89,920
출판사:SAS Institute


For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards Consortium (CDISC) standards. Implementing CDISC Using SAS: An End-to-End Guide, Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy data conversions, and preparing data for regulatory submission. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics included in this new edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, and of course new versions of SAS and JMP software.

Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.


제 1장: 구현 전략
제 2장: Base SAS 구현을 위한 SDTM 메타데이터 및 Define.xml
제 3장: Base SAS를 통한 CDISC SDTM 구현
제 4장: SAS Clinical Standards Toolkit 및 Base SAS를 통한 CDISC SDTM 구현
제 5장: SAS Clinical Data Integration을 통한 CDISC SDTM 구현
제 6장: ADaM 메타데이터 및 ADaM Define.xml
제 7장: Base SAS를 통한 ADaM 구현
제 8장: SAS 사용하여 CDISC 검증
제 9장: Pinnacle 21 Community를 사용하여 CDISC 검증
제 10장: CDISC 데이터 검토 및 분석
제 11장: 통합 데이터 및 규제 제출
제 12장: 기타 주제
번역 후기

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