version 2.1: incorrect DD0082 message

t Thierry

on December 14, 2015

Hi,

When validating a define.xml file (define-xml 2.0), I get the message:

DD0082 Codelist cl.SDTM-Roles is not referenced.

This codelist is referenced, e.g.:

You should also look for references through the optional RoleCodeListOID attribute.

Cheers
-- Thierry

Forums: Troubleshooting and Problems

j Jozef

on December 14, 2015

DD0082

Dear Thierry,

I am not sure about what is meant by this rule.
Do you also have: <CodeList OID="cl.SDTM-Roles" Name="..." DataType="text">...</CodeList> ?

If not, that might be the error.
It might also be that the software (incorrectly) only checks on CodeListRef/@CodeListOID - CodeListDef/@OID pairs and has forgotten to also do so for @RoleCodeListOID.

However, even if a CodeList is defined in a define.xml, but never referenced, this should not give an error. There is no rule in the define.xml specification that forbids this.

m Max

on December 14, 2015

P21

re: version 2.1: incorrect DD0082 message

Hi Thierry and Jozef,

This is a bug. DD0082 is not looking at RoleCodeListOID. We'll have it fixed in v2.1.1.

As far as the merits for the check, DD0082 is the CodeList specific implementation of XML team's published validation rules, specifically 87A. XML team defined this rule as a Warning, but because Pinnacle 21 rules are for regulatory submission it was upgraded to an Error. A sponsor should not submit codelists in Define.xml if they are not being used, thus DD0082 assumes that a sponsor forgot to reference the codelist from a variable.

Thanks for the feedback,

Max

j Jozef

on December 15, 2015

incorrect DD0082 message

Dear Max,

Many thanks for your answer.
It is my personal opinion that Pinnacle 21 should not promote a by the CDISC team set "warning" to "error", even not with the argument that this involves a regulatory submission. If the FDA states that in the define.xml no codelists should be present that are not referenced, this should be an FDACxxx rule and not a Pinnacle 21 rule.

Also a suggestion: Please add some checkboxes to the GUI with e.g. "FDA regulatory submission" and "PMDA regulatory submission", and apply the rules according to which of the checkboxes is checked. We do now already see that FDA and PMDA rules are not identical, and the user should be able to decide against which set of rules to validate, or just validate against CDISC rules and omitting the FDA and PMDA rules, e.g. for SDTM datasets that are never submitted.

Best regards,

Jozef