j Joe
on

 

All,

Hi there.  I am new to the OpenCDISC validator tool and made some progress with my delimited datasets but:

 I am getting numerous errors re codelists e.g. "...Lab Test or Examination Short Name (LBTESTCD) variable values should be populated with terms found in 'Laboratory Test Code' (C65047) CDISC controlled terminology codelist..."

I think I am mising something pretty fundamental here, namely the inclusion of the codelist(s) datasets somehow during the validation process.  Any help much appreciated; I realize this is a naive question.  If anyone could please tell me what file needs inclusion and how I might go about that, it would be much appreciated.  (We've evaluated SAS Clinical Standards Toolkit but frankly not clear which of its result sets or other outputs are needed ; we ran the IQ for it which created several deliverables.  Which one could be used here for the codelists, and how ?  Within the context of open CDISC ?"  All I am feeding it right now is the domain datasets, which is apparently insufficient. 

Thanks much for any insight you can share,

 

Update: I understand from the literature that the file I want is the so-called 'codelist'  file (Gerlash). 

Can someone please tell me where this is supposed to be located to function within the Open CDISDC validator ?? I see the sample but I would like to know where the active one is supposed to reside.  If anyone has a sample 'codelist' file to share it would be much appreciated, along with an explication of where it is to be placed within the OpenCDISC Validator in order to be operant. 

 

Forums: Troubleshooting and Problems

s Sergiy
on October 30, 2012

Hi!

In short, most likely you are OK! There is no real issue in your case.

There are two separate validation checks around a LBTESTCD codelist.

1. SD0037 compares values in datasets vs. a codelist provided in define.xml file. If there is no define.xml, those check is not executed.

2. CT0022 compares LBTESTCD values in the LB dataset vs. CDISC Control Terminology 'Laboratory Test Code' (C65047). This particular list is extensible and new values may be added. The CT0022 checks generates a Warning which in this case should be considered as something like an Informational message. If your new value is really an extension of existing CDISC Codelist, then you are fine. CT0022 validation warnings are generated to review all new non-CDISC Terminology Codelits for a potential misuse:

- usage of new terms instead of existed ones with the same meaning

- spliting of terms, rather than new terms. E.g., Location: ARM -> "Right Arm" and "Left Arm" terms are still "Arm". A new variable Laterality should be added instead. 

- etc.

Regards, 
Sergiy

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