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1. The ODM file must be a well-formed XML file. See the XML standard for details.
2. The ODM file must conform to the XML Namespace standard. See the XML Namespace standard for details.
3. 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.
4. The ODM file must contain a single (top-level) ODM element
5. The ODM file must use the ODM 2.0 namespace, which is "http://www.cdisc.org/ns/odm/v2.0"
6. The ODMVersion attribute on the top-level ODM element must be set to "2.0"
7. The ODM file should begin with a prolog, or XML declaration, as this is considered a best practice 

The schema for version Version 2.0 of the ODM can be found at https://github.com/cdisc-org/DataExchange-ODM.

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<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v2.0"
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
 
    xsi:schemaLocation="http://www.cdisc.org/ns/odm/v2.0 ODM2-0-0.xsd"
 
    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">

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The semantic constraints are expressed throughout the rest of this document.

The ODM version Version 2.0 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.

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