Style Sheet for Define.xml

Style Sheet for Define.xml

The stylesheet is the responsibility of the sponsor ...
For define-xml 2.0, you can find some at: https://wiki.cdisc.org/display/PUB/Stylesheet+Library
For define-xml 2.1, you can get the usual one from the distribution package at https://www.cdisc.org/standards/data-exchange/define-xml/define-xml-v2-1

There are no stylesheets that work with all browsers, as it are the browsers who decide whether to accept stylesheets in general or not. So, don't blame the stylesheet ...
Better is to generate a "define.html" by local processing using an XSLT processor like Saxon (https://saxonica.com/welcome/welcome.xml). See e.g. https://www.cdisc.org/sites/default/files/pdf/DefineXML-Office-Hours-FINAL.pdf slide 24.
You say that the stylesheets you used do not open PDFs at the correct page. Don't blame the stylesheet for that, but your Adobe settings...

I see that you have limited understanding about how define.xml works (maybe you generated it using "black box" software), so I would recommend that you take a CDISC Define-XML training, after which you will be the Define-XML expert in your company: https://www.cdisc.org/education/course/define-xml

Thanks for your response. I…

Thanks for your response. I am admittedly not an expert in style sheets. I am trying to provide the sponsor with the best possible style sheet as a good service to them.

It seems that there are security risks with the browsers using style sheets so my company is blocking their use on some browsers. Are people going to the HTML version as an alternative to the XML now? The FDA is probably still using the define.xml, but compatibility would be getting harder to manage? 

Style Sheet for Define.xml

It is probably not your company blocking the use of stylesheets in the browsers, but the browser manufacturers themselves.
Your sentence "the FDA is probably still using the define.xml" is a bit weird:
The define.xml is a machine-readable XML document, whereas what you (hope to) see in the browser is just a VIEW on the contents of the define.xml, with the stylesheet providing the translation (or better: transformation) from XML to HTML. Or otherwise said: please do distinguish between the XML of the define.xml and the VIEW on it.
If you take the CDISC course, you will learn that the stylesheet visualizes the content of the define.xml, but not everything of it. So the stylesheet also acts as some kind of filter.

If you produce the HTML from the define.xml (using an XSL transformer), the generated HTML does not replace the define.xml at all, so the HTML is not an alternative for the XML at all. You still need to submit both - the XML define.xml can and is used for many other things than just for visualization. For example, for validating the contents of the dataset against the metadata of the submission, which is in ... the define.xml (as XML).

So, once again, I encourage you to take the CDISC course, so that you are able to understand the fundamentals of the Define-XML standard and what it is for (and much more).

Lex

on August 3, 2023

Creating an HTML rendition from a Define-XML document

In this blog post you can find detailed steps about how to create an HTML rendition of a Define-XML document that will open in any (modern) browser:

https://swhume.github.io/blog-2022-generate-html-from-xml.html
 

Style Sheet for Define.xml

I see. Thank you Jozef for taking the time to write a detailed response. I think it will help other people besides just me. I was very focused on the display of the define.xml in browsers, but what I'm hearing is to focus on a high quality define.xml that runs clean with Pinnacle 21 and then also create the .html version and submit both of these. The FDA can use their preferred method to view the define.xml / define.html and all of their automated tools will run on the define.xml. 

Lex, as always you have a resource I need and graciously point me to the right place. Thank you for that link. 

Lex

on August 7, 2023

Stylesheet for Define-XML

Just want to add that I am not aware that the FDA is asking for an HTML rendition. So, if you want to submit the HTML file, you may want to check that it is accepted. Having said that, personally I think a separate HTML rendition makes a lot of sense. It can be easily created, it solves browser issues, and allows stylesheets to be developed that are not restricted to an outdated XSLT version that is dictated by browsers.