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| Validating a CDISC SDTM SAS Data Set |
Introduction to CDISC SDTM
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.
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