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This guide also references the following CDISC standards to support data exchange:

  • Version 1.0 Lab-XML (Placeholder - This is not a model. Updates to text pending.)
  • Version 2.0 of the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), which provides a vendor-neutral, platform-independent format for representing and exchanging case report form content in electronic data capture (EDC) tools.
  • Version 2.1 of the CDISC Define-XML (Define-XML, available at ), which provides a metadata standard used to describe any tabular dataset structure.





  • general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model.
  • Version 2.0 ODM-XML, ODM-XML (Placeholder)is a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information. ODM-XML facilitates the regulatory-compliant acquisition, archival and exchange of metadata and data. It has become the language of choice for representing case report form content in many electronic data capture (EDC) tools
  • Version 2.1 Define-XML. (Placeholder)

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