An Introduction to Creating Standardized Clinical Trial Data with SAS
- Length: 238 pages
- Edition: 1
- Language: English
- Publisher: SAS Institute
- Publication Date: 2022-08-17
- ISBN-10: 195597795X
- ISBN-13: 9781955977951
- Sales Rank: #1030504 (See Top 100 Books)
An indispensable guide for statistical programmers in the pharmaceutical industry.
Statistical programmers in the pharmaceutical industry need to create standardized clinical data using rules created and governed by the Clinical Data Interchange Standards Consortium (CDISC). This book introduces the basic concepts, pharmaceutical industry knowledge, and SAS programming practices that every programmer needs to know to comply with regulatory requirements. Step-by-step, you will learn how data should be structured at each stage of the process from annotating electronic Case Report Forms (eCRFs) and defining the relationship between SDTM and ADaM, to understanding how to generate a Define-XML file to transmit metadata. Filled with clear explanations and example code, this book focuses only on the essential information that entry-level programmers need to succeed.
Front Cover Copyright Page Table of Contents About This Book Chapter 1: Understanding the Industry Chapter 2: Getting Started from the Case Report Form Chapter 3: Study Data Tabulation Model (SDTM) Chapter 4: Analysis Data Model (ADaM) Chapter 5: Case Report Tabulation Data Definition (Define-XML) Appendix Learn More
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