m Manolya
on

 

Hi!

I have a questions regarding the define.xsl 2-0-0. Using this xsl does not automatically mean that I am using Define.xml V2.0, or? I can still use xsl 2-0-0 and xml V1.0? Since the Define.xml V2.0 is not yet covered by the CDISC checker, I would rather go with the Define.xml V1.0.

Thanks in Advance!

 

Forums: Define.xml

l Lex
on July 26, 2013

The example stylesheet that came with Define-XML v2 will not work with Define-XML v1. You may find a similar stylesheet for Define-XML v1 at the updated CDISC/FDA pilot project: 

http://www.cdisc.org/sdtm-adam-pilot-project

Not only is the Define-XML v2 not covered yet by Open CDISC, but the FDA does not accept Define-XML v2 yet.

 

 

 

m Manolya
on July 30, 2013

Hi!

I used the define.xsl 2-0-0 stylesheet and it worked. However, the output was a little different that with stylesheet 1-0-0.

But thanks for the link above! Since when is this pilot project available? However, the nesting is not covered in that updated xsl, correct? That's why I am actually using xsl 2-0-0. But with sponsor's agreement one could change the stylesheet accordingly, right?

l Lex
on July 30, 2013

I guess I was confused in thinking that you tried to use the stylesheet that came with Define-XML v2. I think you used the define.xsl 2-0-0 stylesheet that came with the Metadata Submission Guideline. The pilot project was published early this year.

The stylesheet is not part of the standard, and thus can be changed by the sponsor. One just need to be sure that the stylesheet works in the environment of the agency that it is submitted to. A test submission might be a way to ensure this.

m Manolya
on July 30, 2013

Sorry for the confusion. Yes, I meant the stylesheet that came with the Metadata Submission Guideline. So that is also made for xml V1.0 I suppose. Great. The thing is that the sponsor also thought that I will be creating define.xml V2.0 by using xsl 2-0-0. I was confused. So I can keep going on with stylesheet 2-0-0 from MSG.

I hope I got it now;-).

Thanks a lot for your help!

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