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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.

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