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 Submissions 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, and 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.