Implementing CDISC Using SAS

2nd Edition

An End-to-End Guide, Revised Second Edition

Chris Holland; Jack Shostak
eISBN-13: 9781642952414

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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. This allows users to specify dataset order explicitly in their define files via metadata instead of simply where the data first occurs in the spreadsheet.

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.

Book Review

"This book is beneficial because it fills this gap by describing how to achieve full end-to-end implementation in an everyday nuts-and-bolts approach. The appendices provide example data, SAS code, and metadata spreadsheets, which provide the opportunity to accelerate the hands-on learning of CDISC implementation. The authors have done a great job updating the content in this new edition so that it is harmonized with current published standards and regulatory requirements."

Susan J. Kenny, PhD
Maximum Likelihood, Inc.

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Sold By SAS Institute
ISBNs 9781642952650, 9781642952445, 9781642952414, 9781642952438
Publish Year 2016
Language English
Number of Pages 294
Edition 2nd