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The ODM has been designed to provide a standard format for interchange and archive of clinical study data and metadata. Although the model has proven to be usable with a wide variety of clinical data applications, it is sometimes the case that individual clinical data systems store information that cannot be expressed conveniently in the ODM model. To encourage these systems to adopt the use of the ODM standard for interchange and archive and to improve interoperability of clinical research applications, the use of the ODM vendor extensions is recommended.

Requirements for vendor extensions to the ODM model are:

1. The vendor Vendors must supply an XML or JSON Schema fully describing their extended ODM format.
2. Extended ODM files should reference the proper extension Schemaschema.
3. The extension may add new XML elements and attributes, but may not render any standard ODM elements or attributes obsolete. Vendor extensions Extensions cannot be used for information that is normally expressed using other ODM elements.
4. All For extensions represented in XML, all new elements and attributes must use distinct XML namespaces to insure to ensure that there are no naming conflicts with other extensions. Because JSON does not support namespaces, extensions represented in JSON must ensure no naming conflicts exist with the ODM standard as well as any other vendor extensions involved in the targeted use cases.
5. Removing all vendor extensions from an extended ODM file must result in a meaningful and accurate standard ODM file.
6. Vendors Implementers should be able to produce ODM files free of any vendor extensions upon request.

Applications that use extended ODM files must also accept standard ODM files.

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