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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 CDASH-compliant CRFs for data collection and exchange of tabulation and analysis datasets through provision of data-definition documents to describe datasets. Standards referenced in this section are supported by the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm). ODM -XML is a vendor-neutral, platform-independent format for exchanging and archiving research data, along with their associated metadata, administrative data, reference data, and audit information.
Accessing CDASH Compliant -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. All example CRFs in Examples Section x3.x3, 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
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Creating Data Definition 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 which describe the structure and contents of tabulation and analysis datasets. Define-XML documents provide both a machine-readable format for use by various software applications and, through the provision of an XSL stylesheet, a browser-based rendition describing the metadata attributes of tabulation and analysis datasets. The Define-XML model is implemented using extensions to the ODM-XML schema.
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