Books

This book offers a comprehensive introduction to topics that are essential for establishing a strong foundation in the field of clinical data standardization. It aims to benefit individuals at the onset of their career, including students entering the workforce, as well as professionals seeking to transition into this field.

The approach taken in this book involves two primary stages. First, we concentrate on establishing a solid grasp of fundamental concepts in clinical trials pertaining to clinical data standards. This section will prove particularly beneficial for individuals with no experience in clinical research. Second, we delve into technical aspects concerning clinical data standards, catering to those who may lack data expertise or technical backgrounds. Once this foundational knowledge is established, we proceed to explore the Study Data Tabulation Model or SDTM, a data model employed for standardizing clinical data. Finally, we address scenarios associated with clinical data standardization.