Implementing CDISC Using SAS : An End-to-End Guide / / Chris Holland, Jack Shostak

• Autore: Holland Chris
• Pubblicazione: [Place of publication not identified] : , : SAS Institute, , 2016; ©2016
• Edizione: Second Edition.
• Descrizione fisica: 1 online resource (294 pages)
• Disciplina: 519.53602855369
• Soggetto topico: SAS (Computer file)
• Persona (resp. second.): ShostakJack
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: About This Book -- About These Authors -- Chapter Summary -- SDTM Metadata and Define xml for Base SAS Implementation -- Implementing the CDISC SDTM with Base -- Implementing CDISC SDTM with the SAS Clinical Standards -- Implementing the CDISC SDTM with SAS Clinical Data Integration -- SAS Clinical Data Integration Study Setup -- ADaM Metadata and ADaM Define xml -- Implementing ADaM with Base -- CDISC Validation Using -- CDISC Validation Using Pinnacle 21 Community -- CDISC Data Review and Analysis -- Integrated Data and Regulatory Submissions -- Other Topics -- Source Data Programs -- SDTM Metadata -- run_p21v SAS macro -- Copyright.
• Sommario/riassunto: 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, Revised 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 edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. 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.
• Altri titoli varianti: Implementing CDISC Using SAS
• Titolo autorizzato: Implementing CDISC Using SAS
• ISBN: 1-62960-538-7
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910154889203321
• Lo trovi qui: Univ. Federico II