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ODM

Please visit the Operational Data Model (ODM) page on the CDISC web site for more information about ODM https://www.cdisc.org/standards/data-exchange/odm.

This is version 2.0 of the Operational Data Model (ODM), which replaces version 1.3.2. The ODM 2.0 specification can be found at the CDISC Wiki.

ODM is a vendor neutral, platform independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. All of the information that needs to be shared among different software systems during the setup, operation, analysis, submission or for long term retention as part of an archive is included in the model.