Implementing CDISC Using SAS: An End-to-End Guide

For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have written 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 is an all-inclusive guide on how to implement and analyze Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submissions. Topics covered include 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.

Anyone dealing with CDISC standards--including SAS or JMP programmers, statisticians, and data managers in the pharmaceutical, biotechnology, or medical device industries--will find the philosophical best practices and implementation examples in this book invaluable.

About the Authors

Chris Holland has been a SAS user since 1990. He currently works as a Biostatistics Director for Amgen and has prior experience heading up biostatistics departments for Sucampo Pharmaceuticals, MacroGenics, and Micromet. He has also worked 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 review team, which included FDA staff involved with assessing the suitability of CDISC standards for meeting the needs of medical and statistical reviewers. 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, and a BS in Statistics from Virginia Polytechnic Institute and State University. He is an Accredited Professional Statistician™ by the American Statistical Association.

Jack Shostak, Associate Director of Statistics, manages a group of statistical programmers at the Duke Clinical Research Institute. A SAS user since 1985, he is the author of SAS Programming in the Pharmaceutical Industry, and coauthor of Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, both published by SAS Press. Shostak has published papers for the Pharmaceutical SAS Users Group (PharmaSUG) and the NorthEast SAS Users Group (NESUG), and he contributed a chapter, "Reporting and SAS Tool Selection," in the book Reporting from the Field. Jack is active in the CDISC community, contributing to the development of ADaM and the Statistical Domain Analysis Model, and he serves as a CDISC ADaM trainer. He received an MBA from James Madison University, and a BS in Statistics from Virginia Polytechnic Institute and State University.