l Lex


The PhUSE Optimizing the Use of Data Standards Working Group ("Define-XML 2.0 Stylesheet Recommendations") released a new Define-XML 2.0 Stylesheet in November 2018.
This stylesheet is a big improvement over the previous Define-XML v2 stylesheets as published by CDISC.

See: https://wiki.cdisc.org/display/PUB/Stylesheet+Library

For your information, Dmitry Kolosov asked the following questions to edata@fda.hhs.gov, and received the following answers:

  1. Is it acceptable to use the new stylesheet for eSubmissions?
    eData: yes
  1. Is it correct that Define.pdf is not required if this stylesheet is used in a submission with Define-XML 2.0?
    eData: if the define.xml is printable then a define.pdf is not needed. To confirm that a define.xml is printable within the CDER IT environment, it is recommended that the sponsor submit a test version to cder-edata@fda.hhs.gov prior to application submission.
  1. If you have already used the stylesheet to review some of packages, do you have any comments regarding it? The easiest way to distinguish that a new stylesheet is used, is that now VLM is integrated in the dataset variable tables.
    eData: the new stylesheet has been included in some submission packages and it worked fine so far.

We asked the same question to the Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency.
We received the following:

Regarding Question 1 and 2, PMDA does not have detailed requirements for the style sheet of define.xml for electronic data submission.
A style sheet is acceptable if the style sheet can display the information in the define.xml, which is to be submitted to the PMDA.
Please understand that, in general, PMDA does not individually provide the information about the specification of electronic data submitted to PMDA to outside groups.

We hope you be will include this improved Define-XML v2 stylesheet in your software.


Lex Jansen,

on behalf of the PhUSE Optimizing the Use of Data Standards Working Group project entitled "Define-XML 2.0 Stylesheet Recommendations".

Forums: Enhancements and Feature Requests

s Sergiy
on April 12, 2019

Hi Lex, 

Thank you and all your team for developing this new stylesheet!!!

We and some of our clients started using its draft version since September, 2018 even before its official release due to some new functionality. My favorite part is a support for Key Variables from SUPPQUAL datasets.

New stylesheet is already replaced its old version in Enterprise. Same is true for an upcoming release of Community early May.

Kind Regards,


l Lex
on April 12, 2019

Thank you, Sergiy,

I'm glad to hear this.


m Mike
on December 28, 2020

Hi Lex and others,

I realize I'm responding now to an old post, so my comment may be outdated or common knowledge by now, but I wanted to mention that for a long time, I was having a difficult time with this stylesheet.  In particular, trying to expand or collapse the VLM wasn't working.  In the end, it looked like the Javascript was using a method (something like getElementByClassName) that hasn't always been supported.  After some research and some playing around, I discovered that when I went to the Tools menu in my browser and chose Compatibility View Settings, that "Display intranet sites in Compatibility View" was ticked.  When I un-ticked it, I no longer had the problem.

I later realized that if I added to your stylesheet one line of code that generated the following, that I didn't need to worry about the compatibility settings:

<meta http-equiv="X-UA-Compatible" content="IE=edge"/>

Just wondering if this has come up before or if you have considered making this addition or something like this.

Mike Molter

w wen
on May 26, 2021

Hi Lex,

is there Chinese stylesheet for define-xml v2? where to download?



on May 26, 2021

Hi Wen, 

You can download Chinese stylesheet from https://www.pinnacle21.com/downloads

Kind Regards,

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