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ODM is the basis for the Define-XML and Dataset-XML standard extensions, and those are used not only for clinical data. However, note that this version of the ODM specification includes references to subjects as defined as a patient participating in the study. ODM has been designed to support extensions as documented in the ODM Extensions section, and many organizations, in addition to CDISC, have created extensions to support requirements that extend beyond those documented in this specification.
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