Operational Data Model
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.
Standards In Production Content:
Version 1.3.2 of the ODM, which replaces 1.3.1, adds a new optional OrderNumber attribute for the EnumeratedItem and CodeListItem elements. Both Define-XML V2.0 and the Study DataSet-XML draft standard reference the ODM 1.3.2 schema.
In the specification document (ODM1-3-2-final.html) section "2.5 Changes from Previous Versions" provides a summary of new features added in this release. Detailed descriptions of the new features have been incorporated into the text of the specification document. ODM Version 1.3.2 is designed to provide backward compatibility with previous versions of the model in most cases, and is completely backward compatible with ODM 1.3.1. In cases where backward compatibility has been impacted, it is due to clarifying the specification to more completely match the original intent of the standard.
ODM 1.3.2 has the same namespace as 1.3.1 and 1.3.0. Use ODMVersion to indicate the version used. ODMVersion is enumerated and the list of options is shown in the specification.
ODM version 1.3.1 is available here
You can download the standard as separate elements: