Book description
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.Table of contents
- About This Book
- About The Authors
- Acknowledgments
- Chapter 1: Implementation Strategies
- Chapter 2: SDTM Metadata and Define.xml for Base SAS Implementation
- Chapter 3: Implementing the CDISC SDTM with Base SAS
- Chapter 4: Implementing CDISC SDTM with the SAS Clinical Standards Toolkit and Base SAS
-
Chapter 5: Implementing the CDISC SDTM with SAS Clnical Data Integration
- SAS Clinical Data Integration Introduction
- SAS Clinical Data Integration Metadata
- SAS Clinical Data Integration Study Setup
-
Creating SDTM Domains
- Creating the Special-Purpose DM and SUPPDM Domain
- Creating the AE (Adverse Events) Events Domain
- Creating the XP Pain Scale Customized Findings Domain
- Creating the EX Exposure Interventions Domain
- Creating the LB Laboratory Findings Domain
- Creating the Trial Design Model Domains
- Using Customized Code in SDTM Production
- Templating Your SDTM Conversion Jobs for Reuse
- Using SAS Clinical Data Integration to Create define.xml
- Chapter Summary
- Chapter 6: ADaM Metadata and ADaM Define.xml
- Chapter 7: Implementing ADaM
- Chapter 8: SDTM Validation
- Chapter 9: Validating ADaM Data
- Chapter 10: CDISC Data Review and Analysis
- Chapter 11: Integrated Data and Regulatory Submissions
- Chapter 12: Other Topics
- Appendix A: Source Data Programs
- Appendix B: SDTM Metadata
-
Appendix C: ADaM Metadata
- Appendix C.1 - Define Header Metadata
- Appendix C.2 - Table of Contents Metadata
- Appendix C.3 - Variable-Level Metadata
- Appendix C.4 - Parameter-Level Metadata
- Appendix C.5 - Computational Method Metadata
- Appendix C.6 - Codelist Metadata
- Appendix C.7 - Analysis Results Metadata
- Appendix C.8 - External Links Metadata
- Appendix D: %make_define SAS Macro
- Index
Product information
- Title: Implementing CDISC Using SAS
- Author(s):
- Release date: December 2012
- Publisher(s): SAS Institute
- ISBN: 9781629592459
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