Generating Define-XML: new software

Although my posting "Creating define.xml - best and worst practices" is the most read blog entry of my blog site, people seem not to learn (or maybe do not want to learn). Almost daily, I read complaints of people who use "black box software" for generating define.xml that is free of charge, starting from Excel worksheets, and not getting the result they would like to obtain, at least not when viewing the define.xml visualized by the stylesheet. Some even do not realize that what they see in the browser is not the define.xml, but only a visualization of it.

There does not seem to be much user-friendly software on the market for generating or working with Define-XML. As already explained in the above-mentioned blog, the best way to generate a define.xml is "upfront" and a few software software packages for mapping to SDTM and at the same time generating a good define.xml exist. One of them is my own SDTM-ETL software.

For people that cannot use this approach (e.g. for legacy studies), there was not much out there yet. They usually used the "Excel" approach, often leading to very bad results.

We recently released a new software named the "ODM Study and Define,xml Designer 2016", which can be used for both setting up study designs in ODM format and for generating define.xml files. For the latter, 4 use cases are supported:

• creating a define,xml from scratch
• creating a define.xml starting from an SDTM template (SDTM 1.2, 1.3 or 1.4 - SDTM-IG 3.1.2, 3.1.3 or 3.2)
• creating a define.xml starting from a set of SAS-XPT files
• starting from an incomplete define.xml file, e.g. generated by other tools

In all cases, the user can choose between define.xml v.1.0 and v.2.0. Also the upcoming v.2.1 will be supported as soon as it published by CDISC. The user can also choose between all CDISC controlled terminology versions that were released since 2013.

Unlike the "black box tools", the software comes with a very nice graphical user interface, has very many wizards, and performs validation using validation rules developed by CDISC. For example for generating the define.xml v.2.0 "Where Clauses", there is a wizard:

making it extremely easy to develop "where-clauses". 

At each moment during the process, the user can inspect the generated define.xml, either as XML, as a tree structure, or visualized in the user's favorite browser, and using the default CDISC stylesheet or using an own stylesheet. 

The validation features go beyond anything else that is currently available, and can be done on different levels. Moreover, unlike with other tools, no false positive errors are generated. This is due to the fact that the developer of the software (well, that's me, a CDISC volunteer for 15 years now) is one of the co-developers of the Define-XML standard, and a CDISC authorized Define-XML trainer (I give most of the CDISC Define-XML trainings in Europe), and thus knows every detail of the standard.

The software is not free-of-charge, but it is not expensive either. So, there is now no excuse anymore for generating bad define.xml files!

Information, including a user manual, can be found at:
http://www.xml4pharma.com/CDISC_Products/ODM-Define_Designer_2016.html