m Mingfeng
on

 

Dear all,

I'm creating the define.xml by using all xpt files. But the contents for codelist and valuelist is missing in the define.xml.  That is , the define.xml only contains the Itemgroupdef and Itemdef .

What could be the problem?

Thanks a lot!

John Zhou

Forums: Define.xml

j Jozef
on December 13, 2017

CodeLists and ValueLists do not create themselves just like that. How could they?
You have to specify them in your Excel that will then create the define.xml. Even better is to use a user-friendly tool that has a graphical user interface and works with wizards. A quick internet search "define.xml design software" will provide you with a number of possibilities.

m Mingfeng
on December 13, 2017

Thanks XML4Pharma,

But could I create the CodeList and ValueLists in define.xml by Pinnacle 21 after I specify them in my Excel? And how to specify them in my Excel?  I would be very grateful for your possible Excel template. 

What's more, thanks for you suggestion about innternet search "define.xml design software" , I will have a try.

Looking forward to your reply, best wishes for you !

j Jozef
on December 14, 2017

Well, that is exactly why I never use that tool. There is no user manual. It is suggested that you take an existing define.xml that is good, create the Excel worksheet, and then adapt that Excel worksheet for your own situation / datasets / submission. Essentially "trial and error".

m Mingfeng
on December 14, 2017

Thanks for your suggestion, but I can't find a existing and well-formed define.xml on the Internet. I have researched the define.xml in SAS  official website, but always happend many warnings and errors when it was validated by Pinnacle 21.

And if it's convenient for you, will you please tell me what tool you using now ? 

Best wishes for you !

John Zhou

l Lex
on December 14, 2017

Hi John,

you can go to the CDISC website (https://www.cdisc.org/standards/transport/define-xml), where you can download the Define-XML 2.0 release package, which includes a well-formed Define-XML file.

I would be interested to know which Define-XML you have researched on the SAS official website that contained many warnings and errors. I'm not aware of this. What kind of errors did you see?

Since you seem to be coming from a SAS background, you may also want to look at the SAS Clinical Standards Toolkit
(http://support.sas.com/rnd/base/cdisc/cst/index.html).
Or you can read a paper and presentation I did on CST:

    http://www.lexjansen.com/pharmasug/2017/SS/PharmaSUG-2017-SS08.pdf

    http://www.lexjansen.com/pharmasug/2017/SS/PharmaSUG-2017-SS08-PPT.pdf

Hope this helps.

Lex Jansen
Principal Software Developer at SAS
Standards Developer at CDISC Define-XML team

m Mingfeng
on December 15, 2017

Thanks for you reply, actually, I also try to validate the define.xml in CDISC by Pinnacle , but it still happened some errors.

The define.xml path is :..\define_xml_2_0_releasepackage20140424\sdtm\define2-0-0-example-sdtm.xml.

And it's full name is define2-0-0-example-sdtm.xml.

A example error as follows:

Message:Term/NCI Code mismatch in Codelist <codelist>Codelist

Description:Term must match the value in CDISC Controlled Terminology for corresponding NCI Code. Define-XML specification represents Term as CodedValue attribute on either EnumeratedItem or CodeListItem elements within CodeList element. NCI Code is represented as Name attribute on Alias element when Context attribute is "nci:ExtCodeID".

Category:Terminology

Error:Term/NCI Code mismatch in Codelist 'ECG Test Code'

So I don't know what type define.xml is well-formed , or it's Pinnacle 21 problems?

What's more, thanks for your suggestions about the SAS Clinical Standards Toolkit  and  two papers, I'll have a try.

Best wishes to you,

John Zhou

l Lex
on December 15, 2017

The XML file that you mention, and Define-XML files that you would find at the SAS site are:

- Well-formed, which means they follow the basic XML syntax rules

- Valid according to the XML schema, which is part of the CDISC release package.

The error you mention is most likely because you are not using the same CDISC/NCI Controlled Terminology when validating with P21 as the version that was used to create the Define-XML file.

if you haven’t done so already, I would recommend to take a Define-XML training, as is given on a regular basis by the CDISC organization. You can find information at the CDISC website.

Best, Lex

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