l lv
on

 

Hi Team,

I am using pinnacle 21 to validate a SEND define.xml v2.1, but got an Error below: 

DD0073: For Define-XML v2.0, the Origin Type attribute must have a value of 'CRF', 'Derived', 'Assigned', 'Protocol', 'eDT', or 'Predecessor' for SDTM and ADaM data and 'COLLECTED', 'DERIVED', 'OTHER', or 'NOT AVAILABLE' for SEND data. For Define-XML v2.1, the Origin Type attribute must have a value of 'Collected', 'Derived', 'Assigned', 'Protocol', or 'Predecessor' for SDTM and SEND data and 'Derived', 'Assigned', or 'Predecessor' for ADaM.

But in SEND IG V3.1.1, section 3.2.2.1 Origin Metadata, indicate the origin should be 'COLLECTED', 'DERIVED', 'OTHER', or 'NOT AVAILABLE' ,

In define.xml v2.0 it is match with IG rule, why define.xml v2.1 rule must using 'Collected', 'Derived', 'Assigned', 'Protocol', or 'Predecessor' for SEND? is there any concern on it?

 

Kind regards,

Qianqian

Forums: Define.xml

j Jozef
on July 24, 2024

If you validated a define.xml 2.1 (and indicated so) and get error messages for define.xml 2.0, that is definitely wrong and must be regarded as a bug in the software.
Some background information: the "uppercase" values in 2.0 were added as a temporary solution for the SEND case. In the development of 2.1, we had strong input and cooperation of the SEND team, and agreed on what is specified in the define.xml 2.1 specification (everything lowercase). It looks however that there has been no update for this in the SEND specifications.
If you need more information or have questions, you can always mail me at jozef.aerts@xml4pharma.com.

With best regards,
Jozef

Matt
on July 24, 2024

Hello Qianqian,

 

DD0073 reports the expected values for both Define 2.0 and Define 2.1 in the description. DD0073 fires for Define-XML 2.1 when SEND Origin values are UPPERCASE as for Define 2.1 the values should be propercase following the ORIGINT Codelist

https://library.cdisc.org/browser/#/mdr/ct/2024-03-29/packages/define-xmlct-2024-03-29/codelists/C170449

 

Kind regards,

Matt

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