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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 prolog and a single (top-level) ODM element.
  5. The ODM file must use the ODM 1.3 namespace, which is "http://www.cdisc.org/ns/odm/v1.3"
  6. The ODMVersion attribute on the top level ODM element must be set to "1.3.2"

The schema for version 1.3.2 of the ODM can be found at http://www.cdisc.org/schemas/odm/v1.3. This final version of this specification will be posted at http://www.cdisc.org/odm.

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Info

Example of prolog and top level ODM element:


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#"
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
 
    xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.3 ODM1-3-2.xsd"
 
    ODMVersion="1.3.2"
    FileOID="000-00-0000"
    FileType="Transactional"
    Description="Sample ItemData Extension"
 
    AsOfDateTime="2013-02-04T07:57:00"
    CreationDateTime="2013-02-06T10:30:00">

Example of prolog and top level ODM element:

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#"
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
 
    xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.3 ODM1-3-2.xsd"
 
    ODMVersion="1.3.2"
    FileOID="000-00-0000"
    FileType="Transactional"
    Description="Sample ItemData Extension"
 
    AsOfDateTime="2013-02-04T07:57:00"
    CreationDateTime="2013-02-06T10:30:00">



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

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