s Sandra
on

 

Hello,

Could anybody explain the rationale/source documentation for the checks DD0109:Inconsistent Origin for USUBJID and DD0110: Inconsistent Origin for VISITNUM, I can't find any corresponding CDISC conformance rule or FDA specific requirement?

Thank you,

 

Sandra

 

Forums: Define.xml

j Jozef
on February 21, 2024

As you don't seem to get an answer from P21 ...
This is surely NOT a rule from the CDISC Define-XML team!
It looks to be one of the rules resulting from a note in the "complaint box" at the entrance of the staff restaurant of the FDA White Oak campus.

Probably the idea is that USUBJID and VISITNUM should always be collected or derived/assigned in the same way.
For example, sometimes USUBJID is "derived" by concatenation of study-ID and subject-ID, and the rule then wants that that is always the case.
Similarly, VISITNUM is sometimes derived or assigned, sometimes taken from the CRF (e.g. pre-printed), but the rule wants that this is consistent over the domains.

Do these make sense? I.m.o. not. Suppose that the USUBJID is taken from the CRF when a CRF was used and taken from the data file (non-CRF) in the case of a lab transfer.
Similar for VISITNUM. It can be pre-printed on the CRF, but for the lab transfer need to be derived, e.g. by comparing the collection date with an entry on the CRF (that doesn't have the results).

When one also looks at the entry for these at https://www.pinnacle21.com/validation-rules/define-xml one sees that the "PMDA Severity" is "Warning" (unfortunately "Severity" was removed for FDA, which I think was a very bad decision). In P21 language "Warning" means "there is something unusual, you might want to check it ...". I.m.o., the "Severity" for these 2 rules should not be higher than "Info", but that level doesn't exist.
Although this kind of rules may lead to a lot of superfluous entries/pages in the "Reviewers Guide", the best is to explain the deviation (this is surely not an error against some standard) in the "Reviewers Guide".

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