The syntactic constraints defined by the ODM standard are

   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 namespace for version 1.3 of the ODM is http://www.cdisc.org/ns/odm/v1.3.

 OpenClinica ODM Exports from the Extract Data module meets these constraints.

 Currently, the ODM study definition file (available from the View Study page at the URL /DownloadStudyMetadata?studyId=#) does not meet these requirements for the following reasons:

  1. The file generated from the View Study page is only a fragment of XML, and does not contain the initial tag which defines the character set and version, i.e. <?xml version=”1.0″ encoding=”UTF-8″?>.
  2. The file generated does not contain references to any XML Namespaces, including the namespace for version 1.3 of the ODM itself.
  3. The file generated does contain elements defined in the ODM standard schema, but lacks the single top-level ODM element.
  4. The files suffix is txt instead of xml.

OpenClinica ODM Data Import meets the above constraints, but note that OpenClinica parses everything within the ClinicalData element only, and it does not read anything in the Study element, and, as such, cannot import Study metadata at this time.