ODM v2.0

Published Date:

Public Wiki - ODM v2.0

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 information that needs to be shared among different software systems during the setup, operation, analysis, submission, and archiving of a study are included in the model.

This is Version 2.0 of the ODM. Detailed descriptions of the new features have been incorporated into the text of the specification. ODM v2.0 breaks backward compatibility with previous versions of the model in several ways noted in the specification. 

ODM v2.0 can be serialized as XML, JSON, or other formats. An ODM XML schema is currently available. ODM provides a common base structure for standard extensions easing the learning curve and implementation complexity. A number of CDISC standards have been developed by extending ODM-XML including: Define-XML, SDM-XML, Dataset-XML, Dataset-JSON, CTR-XML and CT-XML.