CDISC SDTM defines
a standard structure for study data tabulation data sets that are
submitted as part of a product application to a regulatory authority
such as the U.S. Food and Drug Administration (FDA). CDISC SDTM was
prepared by the CDISC Submission Data Standards (SDS) team to guide
the organization, structure, and format of the data sets. The data
sets are one of four ways to represent the human subject Case Report
Tabulation (CRT) and equivalent animal data submitted to the FDA.
CDISC SDTM includes
several defined domains that are grouped within broad categories.
The model provides the ability to create custom-defined domains with
sets of standard variable definitions. Variables in common across
domains have similar name extensions. To make them standard, the beginning
prefix of each variable should typically be a two-letter domain code.
PROC CDISC supports
data validation for CDISC SDTM version 3.1.