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Speaker Session on Define.xml at the CDISC Interchange 2018 Berlin on 26th April

Commercial Team


Quanticate's Principal Programmer, Will Greenway, will host a speaker session on Define.xml at the CDISC Interchange Berlin on the 26th April!

Quanticate's Presentation will be part of Session 6, Track A: Define XML on Thursday 26th April at 11:00 AM at the CDISC Interchange conference, Titanic Chaussee Hotel, Chausseestrasse 30, Berlin.

Please find below the abstract of Will's talk:

Define XML – What You See Isn’t Always What You Get

The define.xml is a great way to transfer metadata between organisations but like everything it needs to be handled with care. One of the largest or most common misconceptions seems to be regarding the define.xml contents versus the presented view when opened in a browser with an applied stylesheet. The “I opened it, it looks fine and there were no validation findings, so it’s ok” mentality can miss a lot of genuine issues in the define.xml. Additionally the CDISC example stylesheets are not “THE standard”, but simply a good starting point that can and should be altered when required, or even to aid internal review.

Issues with the stylesheet can be incorrectly interpreted as issues with the underlying xml file but equally since the stylesheet does not show every attribute some genuine issues are going undetected by validators and reviewers alike. Some could be caught with increased validation against the corresponding datasets but others, like a defaulted constant FileOID, although possibly obvious to a human looking through the xml code may be trickier to implement in an automated fashion.

A clear distinction will be made between the define.xml as machine readable code and the stylesheet that transforms the content into a more human-friendly format for viewing, including some of the assumptions made during this transformation.

Attendees will learn how to do some of the easier adjustments that may help them check or view some of the “hidden” metadata and/or show extra information. Some very simple adjustments can lead to questions being raised about the contents of the define.xml or corresponding datasets.

Further to this, some more complex real-life examples will be covered including adding hyperlinks from variables to the Computational Algorithms section for Derived variables, showing Supplemental Qualifiers (from VLM) as Keys for a dataset, conditionally hiding the “Role” column for RELREC dataset (N/A per SDTM-IG), and dealing with Supplemental datasets for Split domains.

This will benefit a great number of attendees, both those wanting to understand/review a define.xml to understand where an issue might lie, and what they might be missing when reviewing. Also those wanting to create or adjust define.xml files properly, which can include adjusting the default stylesheet if needed.


Quanticate prides itself on high data quality and is experienced in the creation of the ‘Case Report Tabulation Data Definition Specification’, aka (define.xml) for submission to the FDA. If you would like to hear more information on Statistical Programming and CDISC services please submit an RFI and we will be happy to get back to you. 


If you would like to discuss in more detail around define.xml and how Quanticate could support your trial, please complete the form below to schedule a meeting with Will Greenway at the conference!

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