Implementing CDISC Using SAS An End to End Guide Revised Second Edition by Chris Holland, Jack Shostak ISBN 1642952443 9781642952445

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Product details:

ISBN 10: 1642952443

ISBN 13: 9781642952445 

Author: Chris Holland, Jack Shostak

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. This allows users to specify dataset order explicitly in their define files via metadata instead of simply where the data first occurs in the spreadsheet.

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.

Table of contents:

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 Clinical Data Integration
Chapter 6: ADaM Metadata and ADAM Define.xml
Chapter 7: Implementing ADaM with Base SAS
Chapter 8: CDISC Validation Using SAS
Chapter 9: CDISC Validation Using Pinnacle 21 Community
Chapter 10: CDISC Data Review and Analysis
Chapter 11: Integrated Data and Regulatory Submissions
Chapter 12: Other Topics

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Tags: Chris Holland, Jack Shostak, Implementing, CDISC, Using SAS, End to End Guide