b Bedeoan
on

 

Hello,

I'm getting the CT0082 and CT0082r errors when validating a dataset without specifing its define.xml. Everything related to CT works fine when I'm specifying define.xml.

Can you please provide some clarification related to this rule? To what "Code in CDISC CT" it refers to?

Best regards,

Amelia

 

Forums: Validation Rule Suggestions

s Sergiy
on October 4, 2013

Hi Amelia, 

There are some "paired" CT codelists. LBTEST (C67154) and LBTESTCD (C65047) are an example of them.

If you look closer you can see that each term in one codelist has a paired term in another codelist with the same Code value. E.g., ALT (C64433) and Alanine Aminotransferase (C64433); BILI (C38037) and Bilirubin (C38037); BILIND (C64483) and Indirect Bilirubin (C64483), etc.

The CT0082/R checks validates such relationship in terms vs. CDISC CT.

E.g., if LBTESTCD='BILI', then LBTEST value is expected to be 'Bilirubin', but not 'Indirect Bilirubin', 'Total Bilirubin', 'Alanine Aminotransferase', 'Blood Pressure' or anything else.

Kind Regards, 

Sergiy

 

m Manolya
on January 7, 2015

Hi Sergij,

 

Can I assign LBTESTCD = BILI also to LBTEST = Total Bilirubin though it is not the CDISC submission value (=Bilirubin)?. The NCI preferred Term says "Total Bilirubin Measurement", so wouldn't it be more appropriate to use "Total Bilirubin" as LBTEST for the submission value?

 

Thanks in advance!

s Sergiy
on January 8, 2015

Hi Manolya, 

CDISC CT has two related codelists:

  • Laboratory Test Code (C65047)
  • Laboratory Test Name (C67154)

"BILI" term from LBTESTCD codelist has a related term "Bilirubinin LBTEST codelist. The relationship is defined by the same "Code" value (C38037) for both "BILI" and "Bilirubin" terms in two codelists.

NCI Preferred Term "Total Bilirubin Measurement" is not applicable for usage in CDISC Control Terminology as replacement for its standard terms. "CDISC Submission Value" column should be used as a source of standard terms.

Kind Regards,

Sergiy 

m Manolya
on January 13, 2015

Thank you, Sergiy!

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