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XSLT : Transformation of CDISC-ODM files

CDISC has recently (April 2002) published the final version of the ODM version 1.1 standard. Before, already a "draft" version was published which was used by several CRO's and pharma companies to learn working with the ODM.

The final version has seen some considerable changes relative to the "draft" version: many attributes have undergone a name change, e.g. all "xxxID" attributes have been changed to "xxxOID" attributes (for a very good reason), some elements were transformed in attributes and vice versa, and some disappeared or were replaced by others. Also a number of new attributes and elements was introduced.

For CRO's and pharma companies this poses the problem that ODM files that were generated under the version 1.1 "draft" have become unusable, as they do not conform to the version 1.1 final specification.

Therefore, we at XML4Pharma, as XML-specialists, have constructed an XSLT stylesheet, which converts ODM XML-files that were generated under the version 1.1 "draft", to ODM XML-files that conform mostly to the version 1.1 "final" version.

ODM XML-file conforming to the draft specification

before the transformation ...

ODM XML-file: output from the XSLT stylesheet

after the transformation ...

The stylesheet has to be used together with an XSLT processor, such as Saxon (we used Saxon 7.0), to transform the "old" ODM XML-files into the new ones. XSLT processors typically can be used from the line-command, or can be very simply incorporated into Java programs (just a few lines of code).

The stylesheet is freely available for download

Important Remarks:

Issues to be solved:


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