ODM v2.0 can be serialized as either XML or JSON.
XML File Conformity
An XML file conforms to the ODM 1v2.3.2 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 v2.0 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.
- The ODM file must use the ODM 1v2.3 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 "12.3.2"0"
- The ODM file should begin with a prolog, or XML declaration, as this is considered a best practice
The XML schema for Version 2.0 The schema for version 1.3.2 of the ODM can be found at httpat https://wwwgithub.com/cdisc.-org/schemas/odm/v1.3DataExchange-ODM. This The final version of this specification will be posted at httpat https://www.cdisc.org/standards/data-exchange/odm.
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Code Block | <?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/ v1.3"
xmlns:ds="http://www.w3.org/2000/09/xmldsig#v2.0" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.3 ODM1-3-2.xsd"
ODMVersion="1.3.2ODMVersion="2.0" FileOID="000-00-0000" FileType="Transactional" Description="Sample ItemData Extension" AsOfDateTime=" 20132022-02 06-04T07:57:00" CreationDateTime="2013 2022-02 06-06T10:30:00"> |
The semantic constraints are expressed throughout the rest of this document.
The ODM version 1Version 2.3 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
The syntactic constraints for ODM v2.0 JSON files are:
- The ODM file must be a well-formed JSON file. See the ECMA-404 standard for details.
- The ODM file must satisfy the rules about element nesting and the formats of values defined in the ODM standard.
- The root object corresponds to the ODM element.
- The ODMVersion attribute of the root object must be set to "2.0".
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{ "ODM": { "ODMVersion": "2.0", "FileOID": "000-00-0000", "FileType": "Transactional", "Description": "Sample ItemData Extension", "AsOfDateTime": "2022-06-04T07:57:00", "CreationDateTime": "2022-06-06T10:30:00", "Study": { "OID": "xxx", "StudyName": "NIH Chronic Low Back Pain example", "MetaDataVersion": { "OID": "yyy", ... } } } } |
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