Operational Data Model (ODM)-XML
ODM-XML 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.
ODM-XML v1.3.2 is the most current version of the standard. A number of CDISC standards have been developed by extending ODM-XML including: Define-XML, SDM-XML, Dataset-XML, CTR-XML and CT-XML. ODM-XML provides a common base structure for these standard extensions easing the learning curve and implementation complexity.