DD0111 False positive?

s Sandra

on September 22, 2023

Hi,

I'm validating a Define-xml v2.1 using P21 Community 4.0.2, engine FDA 2204.1

I have a validation message "Invalid use of Pages" for variable CMCAT, apparently because I reference a CRF page for an assigned variable.

I thought this was allowed now and as I can see from validation rule "For Define-XML v2.0, the Pages field must be empty when Origin is not 'CRF'. For Define-XML v2.1, the Pages field is required when Origin is 'Collected' and Source is 'Investigator' or 'Subject'. Define-XML specification represents Pages as def:PDFPageRef elements within def:DocumentRef element." So it seems that the "must be empty" rule should have been removed.

What do you think?

Thanks,

Sandra

Forums: Define.xml

j Jozef

on September 24, 2023

DD0111 False positive?

At least for Define-XML 2.1, this seems to be a by P21 invented rule.
There is no such rule in the by CDISC published "Define-XML 2.1Conformance Rules" (https://www.cdisc.org/standards/foundational/define-xml/conformance-rules-define-xml-v2-1).
Of course, in most cases, it would not make sense to reference a page number on the CRF, when the Origin Type is "Assigned", but it is not explicitely forbidden, at least not by CDISC. I could also not find anything that forbids it in the latest FDA "Study Data Technical Conformance Guide".

s Sandra

on September 25, 2023

Hi, Thank you Jozef, I just…

Hi,

Thank you Jozef, I just discover the Define-XML 2.1 Conformance Rules. Note that from Metadata Submission Guidelines v2.0, from their CRF and Define examples and from their statements about non collected variables, my interpretation is that preprinted values on the CRF, which used to have origin CRF until SDTM IG 3.2, should now have origin Assigned, which makes more likely the usage of CRF pages for Assigned variables. Anyway I find it especially useful for --CAT variables.

So indeed maybe the rule should be completed removed, also for Define 2.0.

Kr,

Sandra

j Jozef

on September 25, 2023

DD0111 False positive?

Hi Sandra,

The Origin "CRF" in Define-XML 2.0 has been replace by "Collected" in Define-XML 2.1.
I will check, but in my opinion, when the allowed values are preprinted on the CRF, the Origin will still be "Collected".

Define-XML 2.1 specification on "Origin"