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. This book is part of the SAS Press program.

Bibliographic Level Mode of Issuance: Monograph.

Implementation strategies -- SDTM metadata and define.xml for base SAS implementation -- Implementing the CDISC SDTM with Base SAS -- Implementing CDISC SDTM with the SAS clinical standards toolkit and base SAS -- Implementing the CDISC SDTM with SAS clinical data integration -- ADaM metadata and ADaM define.xml -- Implementing ADaM -- SDTM validation -- Validating ADaM data -- CDISC data review and analysis -- Integrated data and regulatory submissions -- Other topics.