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Standards for data exchange support sharing of structured metadata and data between parties and across different information systems. 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 referenced in this section are based on the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm). ODM-XML is a standard, vendor-neutral, platform-independent format  add more text here.


Accessing CDASH Compliant CRFs 

The CDISC eCRF Portal (available at https://www.cdisc.org/kb/ecrf) is 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.


Creating Data Definition Files

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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