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- 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 single (top-level) ODM element, and it is best practice
- The ODM file must use the ODM 2.0 namespace, which is "http://www.cdisc.org/ns/odm/v2.0"
- The ODMVersion attribute on the top level ODM element must be set to "2.0"
- The ODM file should begin with a prolog, or XML declaration, as this is considered a best practice
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