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What is ODM?
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The CDISC Operational Data Model (ODM), maintained by the CDISC XML Technologies Team, is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. ODM is a vendor neutral, platform-independent format for interchange and archive of clinical study data. The model includes clinical data along with its associated metadata, administrative data, reference data and audit information. All the information that needs to be shared among different software systems during the study setup, operation, analysis, submission or for long-term retention as part of an archive is included in the model. See details on the CDISC ODM certification program, including a list of ODM-certified company products.
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