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PCSTRESU "ng/mL" CT2002 FDAC341 PCSTRESU value not found in 'Unit' extensible codelist Terminology Warning
PCSTRESU and unit
Did you assign the correct codelist to PCSTRESU in your define.xml and did you add the define.xml location in the Validator?
Important is that "define.xml is leading", i.e. it is the "sponsor's truth" about the submission. So the validator must look into your define.xml to see which codelist you assigned to PCSTRESU. But of course you must then provide the define.xml. Did you?
Also take into account that the validator often gives you warnings which i.m.o. should not be more than "INFO". For example, when I add "EPOCH" to my domains (required by the FDA, not by the SDTM standard), I get the WARNING FDC031 "Model permissible variable added into standard domain", when I don't add it I get the warning FDC021 "FDA Expected variable EPOCH not found". So whether you add "EPOCH" or not, you always get a warning about it.
The same might have occurred to you with PCSTRESU.
PCSTRESU and unit
As a follow-up on my previous post...
I am currently reviewing the SDTM submission of a customer, also using the Pinnacle21 Validator (v.2.2.0) among others for checking the conformity of the datasets against the standard. I noticed that, although I provided the define.xml file, I still get similar warnings as you do for some datasets about "xxx not found in extensible codelist". The define.xml that is provided however 100% correctly contains these terms with def:ExtendedValue="Yes" in the associated codelist. So it looks as the validator ignores the define.xml when applying this rule. As such, it looks as the "Warning" needs to be interpreted as "Info".
It is not clear to me under which circumstances this happens or not, I should look into the source code of the validator for that.
Pinnacle21, can you help us understand this? Is there a difference when the define.xml is provided and when it isn't?
Hi Saurabh, …
Hi Saurabh,
Yes, "ng/mL" is a valid standard term. P21 tool produces a false-positive message due to incorrect assignment of (UNIT) instead of (PKUNIT) CDSIC CT to PCSTRESU variable in validation specifications. You need to provide an explanation in SDRG.
This bug will be fixed in the next release of P21.
Note, that Jozef's (a.k.a. XML4Pharma) suggestions are non-relevant for your case due to his confusion between data and metadata validation checks.
Kind Regards,
Sergiy
Hi,
In SDTM PC, I have PCSTRESU unit "ng/mL". "ng/mL" is standard PK Units of Measure C67306. I am getting warning for CT2002 rule, because "ng/mL" is part of "PK Units of Measure" not "Unit".
Is there any way to resolve this warning?
Thanks,
Saurabh