Operational Data Model (ODM)-XML
ODM-XML is a vendor-neutral, platform-independent format for exchanging and archiving clinical study data. ODM-XML includes all information (clinical data, along with its associated metadata, administrative data, reference data, and audit information) necessary to share among different software systems during study setup, operation, analysis, submission and for long-term retention as part of an archive to facilitate the regulatory-compliant acquisition, archive and exchange of metadata and data. ODM has become the language of choice for representing case report form content.
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.