Implementing CDISC Using SAS
An End-to-End Guide, Revised Second Edition (Korean edition)
2nd Edition
Published on 24. July 2020
Book
Paperback/Softback
308 pages
978-1-64295-223-0 (ISBN)
Description
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.
More details
Edition
2nd ed.
Language
Other
Product notice
Paperback (trade)
Unsewn / adhesive bound
Dimensions
Height: 235 mm
Width: 191 mm
Thickness: 17 mm
Weight
579 gr
ISBN-13
978-1-64295-223-0 (9781642952230)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Chris Holland | Jack Shostak
Implementing CDISC Using SAS
An End-to-End Guide, Revised Second Edition (Korean edition)
E-Book
07/2020
2nd Edition
SAS Institute
€40.99
Available for download
Persons
Chris Holland has been a SAS user since 1990 in a variety of settings ranging from academia, contract research organizations, regulatory agencies, and both small and large pharmaceutical and biotechnology companies. He was first introduced to CDISC while working as a statistical reviewer at the Center for Drug Evaluation and Research in the U.S. Food and Drug Administration. There he served as the technical lead for the SDTM/ADaM Pilot Project FDA review team and invented an early version of the MAED Service, an adverse event review tool that made use of data standards and is currently in production at the FDA. Since leaving the FDA, Holland continues to be active in the CDISC community, particularly with the ADaM team. He received an MS in statistics from the University of Virginia, a BS in statistics from Virginia Tech, and is an Accredited Professional Statistician(TM) by the American Statistical Association.