An Introduction to Creating Standardized Clinical Trial Data with SAS
An Introduction to Creating Standardized Clinical Trial Data with SAS by Todd Case is a comprehensive resource published by SAS Institute on August 17, 2022. This 240-page guide is designed for statistical programmers in the pharmaceutical industry, providing essential knowledge and practices for creating standardized clinical data in compliance with the Clinical Data Interchange Standards Consortium (CDISC) regulations.
Readers will find a structured approach to understanding the necessary programming techniques and industry standards. The book covers key topics such as annotating electronic Case Report Forms (eCRFs), defining the relationship between SDTM and ADaM, and generating Define-XML files for metadata transmission. With clear explanations and example code, this edition serves as a practical tool for entry-level programmers seeking to navigate the complexities of clinical trial data management.
Official synopsis Publisher
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.
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