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The CDISC-ODM is the new standard for exchange of
clinical data information. A very simple example of a CDISC-ODM file in XML-format is given here.
The XML example file contains information about a clinical trial study
performed on a few patients only.
The contents of the file (the clinical data) can be presented as HTML, WAP, Word, RTF, or any other presentation format, using a stylesheet. These stylesheets are typically written in XSL (which is XML itself). Here we give the data presented in PDF, as the result from the XSL-stylesheet (Note).
(Work continuously in progress - find a new improved version every few weeks)
Full version (892kB, 238 pages)
Short version
(159kB, 34 pages - for those with a slow connection)
This example also includes a picture, in order to demonstrate how to include
extra (graphical) information - more
...
When using a stylesheet, the presentation of the data remains the same, even when the data change. So, the stylsheet we developed can also be used for much more complicated clinical data files.
The PDF-file, as the result of the stylesheet, shows a number of the
features of using stylesheets. External images can be used for making the
resulting document more attractive (or more informative), extra text can be
added, page numbering is automatic, colors may be used extensively (you might
dislike my choices, but that is a matter of taste), and tables can be easily
produced.
A closer look at the result shows how tables, which span over more than 1
page, automatically get headers again on the new page.
It is even possible (not implemented in these examples), to perform automatic highlighting when a
value exceeds or gets below a certain threshold (threshold is given in the
stylesheet).
We used the same stylesheet to transform a number of different CDISC ODM files:
| A CDISC ODM file presented at the CDISC Connectathon at the DIA 38th Annual Meeting, Chicago, June 2002 | The PDF result (964kB, 295 pages) |
| A CDISC ODM file presented at the CDISC Connectathon at the DIA 11th European Workshop on Clinical Data Management, Paris, October 2001 | The PDF result (907kB, 241 pages) |
| A short version of the above file | The PDF result (171kB, 39 pages) |
| An other example presented at the CDISC Connectathon | The PDF result (892kB, 238 pages) |
| A short version of the above file | The PDF result (159kB, 34 pages) |
| The newest example
given by CDISC as an example of the final ODM v.1.1 (April 2002) |
The PDF result (59kB, 20 pages) |
Latest changes:
Next to do:
FAQ:
We regularly get questions about the way we presented the data in the PDF document. Here are the most Frequently Asked Questions (and our answer):
More information about the stylesheet as we developed it, is available on request.
