An Introduction to Creating Standardized Clinical Trial Data with SAS

Chapter 3: Study Data Tabulation Model (SDTM)

The Study Data Tabulation Model (SDTM) is a standard structure for human clinical trial data. The data is referred to as a domain and is required as part of a drug or biological submission to a regulatory authority such as the United States Food and Drug Administration (FDA). All SDTM domains are built around the concept of creating observations collected about subjects who participated in a clinical study. The domains are unique, created around topics and comprised of two letters such as DM for Demographics domain, AE for Adverse Events domain, etc., and reflect what has been entered into the CRF. In this chapter we will describe the SDTM data model, including information about the variables, standard ...