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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. All example CRFs in Section Examples Section x.x, Product Impact on Individual Health, may be downloaded in ODM-XML is a standard, vendor-neutral, platform-independent format for representing and exchanging CRF content in and loaded into applicable electronic data capture (EDC) tools which enables . Once loaded into an EDC tool, standard CRFs may then be used as-is or modified per CDISC standards to support needs.

Creating Data Definition Files to Support Data Submission

The CDISC Define-XML Model supports Versupports 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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