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The Operational Data Model (ODM) is a vendor neutral, platform independent data exchange format, intended primarily for interchange and archival of clinical study data pertaining to individual subjects, aggregated collections of subjects, and integrated research studies. 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, and archival of a study are included in the model.
This is version 2.0 of the ODM. Section 2.5 Changes from Previous Versions provides a summary of the new features. Detailed descriptions of the new features have been incorporated into the text of this document. ODM v2.0 breaks backward compatibility with previous versions of the model in several ways noted in the Changes from Previous Versions summary.
ODM v2.0 can be serialized as XML or JSON and an ODM schema is available for each format.
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