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Standards referenced in this section support exchange of standard CRFs for data collection and exchange of tabulation and analysis datasets through provision of data definition files to describe shared datasets. Standards in this section are generally based on the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), is a standard, vendor-neutral, platform-independent format add more text here



Exchanging CRFs

  • CDISC eCRF Portal (available at https://www.cdisc.org/kb/ecrf) and Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), which provide a platform from which to download standard CRFs including metadata standardized per ODM-XML. ODM-XML is a standard, vendor-neutral, platform-independent format for representing and exchanging CRF content in electronic data capture (EDC) tools.


Data Definition Files Define-XML

The CDISC Define-XML Model 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. 

  1. See the SDTM Define-XML specification (https://www.cdisc.org/standards/data-exchange/define-xml) for details regarding metadata representation when a domain is split into different datasets.



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