Implementing CDISC Using SAS: An End-to-End Guide
By Jack Shostak and Chris Holland
Anticipated publication date: Fourth quarter 2012
The Clinical Data Interchange Standards Consortium (CDISC) began in 1997 as a global, open, multidisciplinary, nonprofit organization focused on establishing standards to support the acquisition, exchange, submission and archival of clinical research data and metadata. For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. The first SAS book to deal with CDISC standards, Jack Shostak and Chris Holland’sImplementing CDISC Using SAS: An End-to-End Guide is an all-inclusive guide on how to implement and analyze SDTM and ADaM data and prepare clinical trial data for regulatory submissions. Among the topics covered are: creating and using metadata, implementing and validating SDTM and ADaM, preparing data for regulatory submission, as well as various other topics.