12-07-2016 01:41 PM
Move beyond the 'whys' of CDISC and bridge the gap between theory and practice with this all-inclusive guide!
With the increased attention on the use of the required Clinical Data Interchange Standards Consortium (CDISC) standards, developing an understanding of best practices for efficient implementation of the standards is key and cannot be gained by reading the voluminous publications of the CDISC foundational teams.
Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS to dive deeply into not only the implementation practice, but also the ultimate goal of how to analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission.
The all-inclusive guide has been updated with:
Implementing CDISC Using SAS covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics 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.
Data managers, clinical and/or statistical programmers, biostatisticians, and clinicians will find the philosophical best practices and implementation examples in Implementing CDISC Using SAS: An End-to-End Guide, Second Edition invaluable. The appendices provide example data, code, and metadata spreadsheets, which provide the opportunity to accelerate the hands-on learning of CDISC implementation.
With the end-to-end concept in mind, this book fills a much needed gap with implementing CDISC in an everyday nuts-and-bolts approach.