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.
For your information, Dmitry Kolosov asked the following questions to email@example.com, and received the following answers:
- Is it acceptable to use the new stylesheet for eSubmissions?
- 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 firstname.lastname@example.org prior to application submission.
- 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.
on behalf of the PhUSE Optimizing the Use of Data Standards Working Group project entitled "Define-XML 2.0 Stylesheet Recommendations".
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