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The CDISC ODM Checker is a tool developed by XML4Pharma
to check whether an ODM file conforms to the CDISC standard.
This tool is freely available for CDISC members.
Other tools for working with the CDISC set of standards
Version 0.7 corrects a few minor bugs found in version 0.6
Full list of the new features in v.0.6
A number of demos showing how the tool works can be found here as Macromedia Flash files. If you haven't installed the Flash plugin yet, you can get it from here.
Remark that the demo files aren't small files (0.2 to 0.7 Mb), so downloading can take some time if you have a slow connection. The demos demonstrate the possibilities with the older version of the ODM Checker (v.0.4) - we try to update the movies as soon as possible.
This Flash animation shows the basics of how an ODM XML file can be checked against the CDISC standard.
Start the demo now
This demo shows what happens if an ODM file is checked which is even not valid XML. However, the file also contains some other non-conformities.
Start the demo now
The demo shows the checking of an ODM file which has a large number of inconformities, especially in the Study section
(containing the study setup). As a consequence, in the ClinicalData section (containing the clinical data) even more
non-conformities are found. It is also shown how a check can be performed without checking referential integrity between
Study section and ClinicalData section, i.e. performing a first, rough check without checking against the metadata.
This is especially useful when the Study section contains a good number of non-conformities, as is the case here.
In clinical data practice, the ODM file with the study definition will surely not always be repeated in each ODM file with clinical data. This demo shows how to check a file with clinical data against the metadata (study definition) residing in another file.
A number of well known companies that use our ODM Checker to validate CDISC ODM files are:
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Convinced by the power of the CDISC ODM Checker ?
CDISC members can obtain the CDISC ODM Checker for free, an e-mail containing your full credentials suffices. Non-members may purchase a license. Please contact us for further details.
Companies interested in obtaining a license for incorporating the CDISC ODM Checker into their own system (e.g. as a web service), please contact us. We will be happy to make the necessary adaptions to the CDISC ODM Checker so that it fits into your own IT systems for working with the CDISC set of standards.
The ODM Checker has not been updated (yet) for CDISC ODM 1.3.
However, the ODM team is getting more and more convinced that validation against a standard should at least as possible be relying on software.
Instead, the description of the rules should at much as possible be in an open, human- as well as machine-readable language, i.e. in XML.
XML-Schema is such a language, and as of version 1.2 of the ODM standard, it is the main "rules-enforcement" engine for validation of ODM files.
However, XML-Schema cannot describe all the rules of the standard, and that is exactly why we have developed the ODM Checker.
A new, additional, (W3C standard) rules-based validation language has been emerging during the last years: Schematron. It is very powerful, and allows to describe many of the rules
that cannot be described using XML-Schema. As it is XML itself, it is as well human- as machine-readable.
One of the advantages of publishing a Schematron in addition to an XML-Schema, is that everyone uses the same rules, i.e. different interpretations by different
implementors are avoided.
The CDISC ODM Team and XML4Pharma are currently working on a Schematron for version 1.3 of the ODM standard. As soon as it is ready, we will make it public.
XML4Pharma will then provide a new ODM Checker implementing as well the public XML-Schema as the public Schematron.
