An Introduction to Creating Standardized Clinical Trial Data with SAS

An Introduction to Creating Standardized Clinical Trial Data with SAS
by YuTing Tian and Todd Case
Publisher: ‎SAS Institute (August 19, 2022)
Language: ‎English
Hardcover: ‎238 pages
ISBN-10: ‎1955977984
ISBN-13: ‎9781955977982
Book Description
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.