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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 Examples Section x.x, Product Impact on Individual Health, may be downloaded in ODM-XML format and loaded into applicable electronic data capture (EDC) tools. Once loaded into an EDC tool, standard CRFs may then be used as-is or modified per the TIG and related CDISC standards to support needs.

CDISC Library

The CDISC Library (https://www.cdisc.org/cdisc-library) uses linked data and a REST API to deliver CDISC standards metadata to software applications that automate standards-based processes. CDISC Library provides access to new relationships between standards as well as a substantially increased number of versioned CDISC standards and controlled terminology packages.

Creating Data Definition Files Documents to Support Data Submission

Version 2.1 of the CDISC Define-XML standard (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 provides documents provide both a machine-readable format for use by various software applications and, through the provision of an XSL stylesheet, a browser-based report rendition describing the metadata attributes of tabulation and analysis datasets. The Define-XML Model is an extension of model is implemented using extensions to the ODM-XML Modelschema.