An Introduction to Creating Standardized Clinical Trial Data with SAS - by Todd Case & Yuting Tian (Paperback)

Book Synopsis

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.

Review Quotes

An Introduction to Creating Standardized Clinical Trial Data with SAS is a new book designed to give programmers a jump start into the regulatory requirements of the pharmaceutical industry. This unique book goes behind the scenes to better explain the mechanics of SDTMs and ADaMs. The book has all CDISC programming solutions with a comprehensive collection of SDTM and ADaM examples including trial summary domains. This approach is ideal for those who are new to CDISC and want a complete picture. Assignments, case report form data, and variable derivations follow CDISC and Control Terminology guidelines. SAS programs follow a good programming style with code annotations to explain logic.

Sunil Gupta, SAS/CDISC Consultant, Trainer and Author