Define-xml 2.1 rule coverage - what is the CORE equivalent of P21's DD0003?

[botsp]

Hi,

I noticed the CORE v2.0 roadmap includes Define-xml 2.1 rules.

I have two questions:

1. Is there an active work group for Define-xml 2.1 rules I can join or follow?
2. P21 has a rule DD0003 (related to define-xml CodeList references).
   Will this be covered in the upcoming Define-xml 2.1 ruleset?

Thanks

[JozefAerts]

The conformance rules for Define-XML 2.1 have already been published by CDISC in 2021 at:
https://www.cdisc.org/standards/foundational/define-xml/conformance-rules-define-xml-v2-1.
In the past, I have developed a Schematron for implementation of these rules, which together with XML-Schema, can be used to validate define.xml 2.1 files. These have been implemented in several commercial tools of our company, XML4Pharma.
The XML-Schema and the Schematron can be used as a basis for CORE validation of "define.xml-only" in the future. A decision about the "how" has however not been made yet.
Yes, rules like DD0003 "Required attributes must be included in Define.xml and cannot be empty." will of course be implemented. DD0003 is is however already fully covered by the XML-Schema. So, you can simply do an XML-Schema validation to detect such issues.
A few remarks however:

• the CDISC define.xml validation rules are fully INDEPENDENT of those of P21 (we are even not comparing), they were also developed before the P21 ones.
• P21 has shown several times that their knowledge about XML, XML-schema and define.xml is very limited, often leading to false positives, overinterpretation of the standard.
• P21 requires that with a define.xml validation, also the standard for which the define.xml is provided, is delivered. This is a wrong approach.
  Rules that compare the content of submission files against what is in the define.xml are now already in CORE.

[botsp]

If specifying the version is not required, can it therefore support the differences between Define-XML v2.1 and v2.0, such as Has_no_data?

[JozefAerts]

What I meant is "SDTM", "SEND", "ADaM".
Of course the difference between Define-XML 2.0 and 2.1 is very important, as these have different XML-Schemas, different validation rules and Schematrons.
The rules are however, for 99%, not dependent on whether the define.xml is for SDTM, SEND or ADaM. P21 doesn't think so.
Even more problematic with P21 is that the implementation of the rules is "black box" as P21 is now "closed source", in contradition to CORE, which is fully open source.

[botsp]

Thanks for the clarification. However, distinguishing whether the Define-XML is for SDTM, SEND, or ADaM should be necessary mainly for cross-checking against the datasets? If the Define-XML is being validated independently, specifying the dataset standard would seem unnecessary.

[JozefAerts]

That is something else! These checks, validation of the datasets against define.xml is ALREADY done by CORE NOW.
What we are speaking about is pure Define-XML checking.
P21 is unfortunately mixing up things.

[botsp]

I guess I now understand your concerns. Thanks for sharing your insights!