ODM v2.0

Operational Data Model (ODM) v2.0

CDISC has released version 2.0 of the Operational Data Model (ODM). The 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.
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.
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.
Dataset-JSON is a dataset exchange standard included in ODM.

The Operational Data Model v2.0 has completed the CDISC Standards Development Process and is released for use as Final.
The ODM team will now begin development on a number of supplements to the ODM v2.0 standard, including the JSON schema, an API specification, ODMPath, compressed ODM, streaming ODM, conformance rules, and LinkML representation.