Define-XML v2.1 – What do you think?

If you're wondering where the XML standards like Define-XML went on the CDISC website, they've moved. They're now located under Standards/Transport. If you go to the transport page you can select from a fairly extensive menu of transport standards. There are a few transport options located elsewhere, such as Lab and the Analysis Results Metadata Define-XML extension.

Our broad list of XML standards is in the process of welcoming a new version of Define-XML to the family. This new version of Define-XML, v2.1, will almost certainly be listed in the standards catalogs of regulatory authorities at some point, so all of you working on regulatory submissions should find this update interesting. There are a couple weeks left in the Public Review period (it ends on May 5th) so there's still time to add your comments. You can find the Define-XML v2.1 Public Review package along with instruction for adding JIRA comments on the CDISC wiki.

While Define-XML v2.1 is a minor point release, as opposed to say the move from Define-XML v1.0 (hard to believe we used to call this the Case Report Tabulation Data Definition Specification) to Define-XML v2.0, there are a few major changes included in this update in addition to a number of minor ones. The changes improve the Define-XML's ability to represent study metadata and address all the Define-XML v2.0 errata. The most significant changes include:

  • Enhanced Origin to improve the traceability metadata
  • Versioning of standards and controlled terminology
  • Identifying non-standard domains and variables

The CDISC Define-XML team plans to begin maintaining enumerations of Define-XML terminology in the XML schema to extend what can be verified by the schema alone. These enumerations reflect the valid set of values for specific Define-XML attributes. As new values are created the schema will be updated.  This will increase the number of 2.1.x versions, but will improve the precision of schema validation. This means implementers and validation engines will need to become more aware of schema updates.

Although the style sheet is technically not a normative part of the standard, a new version of the style sheet is under development within the context of a PhUSE team and with the intention of supporting Define-XML versions 2.x. That is, the style sheet will support both Define-XML v2.0 and v2.1. It includes a number of improvements, and we anticipate providing the updated style sheet with the official release of v2.1. It's also in the Public Review package if you're interested in reviewing it along with the license. In case you missed it, the style sheet has a relatively new license associated with it. Last year it was re-released under the very permissive MIT open source license (MIT License with Copyright (c) 2013-2017 Lex Jansen). Please review this if you plan to modify the style sheet or include it in your software.

One final note, Define-XML is machine-readable, so in your v2.1 review it would be useful if you got your machine to give it a read and see what comments are produced that might be worth sharing.


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