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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.
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