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Creating Data Definition Files to Support Data Submission

The CDISC Define-XML Model Versupports Version 2.1 of the CDISC Define-XML (Define-XML, available at https://www.cdisc.org/standards/data-exchange/define-xml/define-xml-v2-1), supports creation of data definition files with which to describe the structure and contents of tabulation and analysis datasets. The Define-XML Model provides both a machine-readable format for use by various software applications and, through the provision of an XSL stylesheet, a browser-based report describing the metadata attributes of tabulation and analysis datasets. The Define-XML Model is an extension of the ODM-XML Model.

The Define-XML standard (available at https://www.cdisc.org/standards/data-exchange/define-xml) specifies metadata attributes to describe SDTM data. Need Version

SDTM 2.2 Datasets and Domains 

Each dataset is described by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document (i.e., a Define-XML document) that is submitted with the data to regulatory authorities. 

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