y Yan
on

 

With the community version 4.0 came the support of define.xml version 2.1. Thank you for the great effort on this very needed feature.

I do have a question regarding the new section "Standards" used in define.xml version 2.1 where all the standards (IG, CT, etc..) can be included in the meta and displayed at the beginning when shown with the stylesheet. From the spreadsheet used by Pinnacle 21 to generate the define.xml 2.0, I could not figure out where to add this information. I do see ADaM/SDTM IG version can be added to the "Standard" column in the "Dataset" tab but I could not locate a place to fill in the other standards such as CT version.

Best regards,

Forums: Define.xml

Sergiy
on April 30, 2022

Hi Yan, 

Please refer to CDISC Define-XML Terminology available at https://evs.nci.nih.gov/ftp1/CDISC/Define-XML/

Note that, for example,  SDTM Controlled Terminology is a Dictionary rather than a Standard.

Kind Regards,
Sergiy

j Jozef
on May 2, 2022

I don't think you will be able to generate a Define-XML 2.1 with the Excel worksheet for 2.0.
First of all, the namespace of all elements is different between 2.0 and 2.1. So, essentially, e.g. an "ItemDef" in 2.1 is a completely different object as in 2.0.

def:Standards and def:Standard are new elements in Define-XML 2.1, so you will not find a place for it in a worksheet meant for 2.0.
Similarly, in 2.1 you can assign a different IG version and different ITversion to each individual dataset definition ("ItemGroupDef"), and you even need to assign the IG and CT version at that level. Assigning the used standard name and version is not possible anymore at the higher level ("MetadataVersion" level).

All this is extremely well explained in the CDISC Define-XML (2.1) one-day training course. There is one once again at the end of this month.

You can always mail me for more information and details. My mail address is easy to find.

Jozef Aerts
CDISC Define-XML Development Team

y Yan
on May 4, 2022

Thank you for your reply. I had a typo in my original post: I meant spreadsheet for define.xml 2.1 not 2.0.

In the new define.xml 2.1, the standard section can have SDTM/ADaM CT version and in the CT section the version is displayed along side the CT name (see screenshot in file upload). I tried to add a name to the "Terminology" column in the "Codelists" tab in the new spreadsheet for 2.1 and add the CT version with the same name in "Dictionaries" tab but that didn't work because the Terminology column added "STD." prefix to the OID whereas dictionary will add "CL." prefix. I can manually add the standard (i.e. <def:Standards>) in the define.xml and that will work but I have not figured out a way to do that through the new define spreadsheet. 

As an example right now all my codelists in define.xml 2.1 "Codelist" section is showing something like "Age Unit [C66781][Non Standard]". I'd like to know what/where I need to add to the define 2.1 spreadsheet to make it display: Age Unit [C66781][CDISC/NCI SDTM 2018-06-29]

Really appreciate your input.

Best,

j Jozef
on May 4, 2022

Thanks,
I can give you more detailed information if you contact me by e-mail.

With best regards,
Jozef Aerts
XML4Pharma
CDISC Define-XML Development Team

y Yan
on May 9, 2022

Thank you Jozef. I didn't find your email from your profile. Do you mind sending me a email at wy507@yahoo.com?

Best regards,

Yang

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