ODM 2.0 can be serialized as either XML or JSON.
XML File Conformity
An XML file conforms to the ODM 12.3.2 0 standard only if it satisfies all the criteria detailed in this standard. These criteria include both syntactic constraints and semantic ones.
The syntactic constraints for ODM 2.0 XML files are:
- The ODM file must be a well-formed XML file. See the XML standard for details.
- The ODM file must conform to the XML Namespace standard. See the XML Namespace standard for details.
- The ODM file must contain only elements and attributes defined in the ODM standard schema or in a valid vendor extension schema, and must satisfy the rules about element nesting and the formats of attribute values and element bodies.
- The ODM file must contain a prolog and a single (top-level) ODM element., and it is best practice
- The ODM file must use the ODM 12.3 0 namespace, which is "http://www.cdisc.org/ns/odm/v1v2.30"
- The ODMVersion attribute on the top level ODM element must be set to "12.3.20"
- The ODM file should begin with a prolog, or XML declaration, as this is considered a best practice
The schema for version 12.3.2 0 of the ODM can be found at httphttps://www.cdisc.org/standards/schemasfoundational/odm/v1.3odm-v2-0. This final version of this specification will be posted at httphttps://www.cdisc.org/standards/data-exchange/odm.
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Example of prolog and top level ODM element:
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The semantic constraints are expressed throughout the rest of this document.
The ODM version 12.3 0 XML Schema file can be used with a validating XML parser to test that an ODM file is syntactically valid. To ensure semantic correctness the use of an ODM-specific validation application is recommended.
JSON File Conformity
TODO
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