Operational Data Model (ODM)

ODM is a vendor-neutral, platform-independent format for exchanging and archiving clinical study data. Maintained by the CDISC XML Technologies Team, ODM is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data. It 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. ODM has become the language of choice for representing case report form content.

 

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

 

Download ODM v1.3.2

 

CDISC offers an ODM certification program to provide assurance that your ODM-capable products can produce ODM files with a high level of conformity to the published specifications.

 

Previous Versions

Download ODM v1.3.1

 

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