Implementing CDISC Using SAS
eBook - ePub

Implementing CDISC Using SAS

An End-to-End Guide, Revised Second Edition

  1. 294 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Implementing CDISC Using SAS

An End-to-End Guide, Revised Second Edition

About this book

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, Revised 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 edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly.

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.

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Yes, you can access Implementing CDISC Using SAS by Chris Holland,Jack Shostak in PDF and/or ePUB format, as well as other popular books in Computer Science & Computer Science General. We have over one million books available in our catalogue for you to explore.

Information

Publisher
SAS Institute
Year
2019
Print ISBN
9781642952445
eBook ISBN
9781642952414
Edition
2
Topic
Computer Science
Subtopic
Computer Science General
Index
Computer Science

Table of contents

  1. Cover
  2. Title Page
  3. Copyright Page
  4. Contents
  5. About the Book
  6. About the Authors
  7. Chapter 1: Implementation Strategies
  8. Chapter 2: SDTM Metadata and Define.xml for Base SAS Implementation
  9. Chapter 3: Implementing the CDISC SDTM with Base SAS
  10. Chapter 4: Implementing CDISC SDTM with the SAS Clinical Standards Toolkit and Base SAS
  11. Chapter 5: Implementing the CDISC SDTM with SAS Clinical Data Integration
  12. Chapter 6: ADaM Metadata and ADaM Define.xml
  13. Chapter 7: Implementing ADaM with Base SAS
  14. Chapter 8: CDISC Validation Using SAS
  15. Chapter 9: CDISC Validation Using Pinnacle 21 Community
  16. Chapter 10: CDISC Data Review and Analysis
  17. Chapter 11: Integrated Data and Regulatory Submissions
  18. Chapter 12: Other Topics
  19. Appendix A: Source Data Programs
  20. Appendix B: SDTM Metadata
  21. Appendix C: ADaM Metadata
  22. Appendix D: %run_p21v.SAS macro
  23. Index