c Cathy
on

 

Hi,

I'm getting DD0074 (Variable/Value Level Origin Type mismatch).  For LBTESTCD at the Variable level the Origin is 'eDT, CRF' because some lab tests come from eDT, some come from CRF, and some could be both. At the Value level the Origin for the specific test is specified as either 'eDT', 'CRF', or 'eDT, CRF'.  Please check.

Thanks! 

Forums: Define.xml

j Jozef
on December 12, 2015

Please see the Define-XML 2.0 specification section 5.3.11.3. def:Origin Element. It states:
"For regulatory submissions, def:Origin metadata must be provided for all SDTM, ADaM or SEND variables. It is at the sponsor's discretion whether to provide def:Origin at the Variable or Value level.", meaning that in your case you can either provide it at LBTESTCD level or the value level ItemDefs for the individual tests (or both, but then, they must be consistent).
The specification further defines a list, and states for the 'Type' attribute: "The list of allowable values is not extensible". This means the Type attribute can (when present) either have the value "CRF", "Derived", "Assigned", "Protocol", "eDT", "Predecessor". A combination of some of them is not allowed.
So in your case, I propose that you do NOT add a def:Origin at the LBTESTCD level ItemDef, but provide one for each ItemDef at the value level ItemDef (one for each test). After that, the error should disappear. If it does not, please let us know.

l Lex
on December 12, 2015

To add to Jozef's comment, you can add multiple def:Origin elements at the Value Level ItemDef elements. 

You can also have more than one def:Origin element at the variable def:ItemDef, when more than one ItemDef/def:Origin/@Type are needed and the rest of the ItemDef attributes do not change. The latter is not the case though in this example. Multiple def:Origin elements will be fully described in Define-XML 2.1.

r Robert
on January 18, 2017

I'm having trouble with DD074 check for Define 2.0, I'm using validator 2.1.3. It is comparing my value level origins (I left the varlevel blank) and telling me that they do not match. This is the "Values" field from the excel report that is coming out. "IT.EG.EGORRES.HRMEAN, IT.EG.EGORRES.INTP, CRF" Then it proceeds to list each TESTCD that is different from HRMEAN. 

Found the issue, the valuelist components were referring to the valuelist so it was comparing valuelevel with all of the valuelevel items. 

s Sergiy
on January 24, 2017

Hi Robert, 

What about v2.2.0?

Thanks,

Sergiy

r Rob
on July 27, 2017

Hi, I am running version 2.2.0 and am also seeing this error. The origin at variable level is blank and I have multiple origin types at Parameter value level metadata. Is this still a known bug in the check?

Rob

 

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