c Carol
on

 

We ran the CDISC Define-XML-2-0_ReleasePackage20140424\adam\define2-0-0-example-adam.xml through the OpenCDISC Community Validator (standard = define.xml , Configuration = Define 2.0.xml ) and incurred 2 errors which should not be errors.  I have attached the OpenCDISC output.

 

Both of these “Terminology” errors are due to the tool crosschecking the define.xml’s codelist CDISC code OIDs against the CDISC controlled terminology file.  However, unlike using Validator to validate against the ADaM standard, validating the define.xml standard does not allow the user to specify the CDISC CT version to use.  So it appears that, not only is the most recent version used, but only the SDTM CT file is used (even for a define.xml for ADaM). 

 

For the first error, DD0027, this codelist code does in fact exist in the ADaM controlled terminology.

For the second error, DD0028, this codelist code does in fact exist in the version of the SDTM CT that was the most recent when the define.xml file was released.  The code has since been demoted, so no longer exists in the most recent SDTM CT version.

 

Although no errors were incurred when using Validator to check the CDISC define.xml version 2 example for SDTM, obviously the same issues are potential problems.

 

I would think that user should be able to specify the CT version used for define.xml standard checking.  Please note that both the SDTM and ADaM CT versions used for ADaM define.xml version 2 checking should be able to be specified.  ADaM datasets will include data from SDTM that need to be represented in the define.xml.  The Codelist codes that will be used for the variables from the SDTM will be the SDTM CT codes.

Forums: Troubleshooting and Problems

s Sergiy
on January 8, 2015

Hi Carol, 

We are aware of this issue and actually have already promised to introduce a selection of CT for define.xml validation in OC Community v2.0

Unfortunately it was not implemented in v2.0 because we are re-designing the whole process for define.xml validation now and decided to not waste resources for a temporary solution.

Sorry for inconvenience. 

A new more robust define.xml validator will be available in 2-3 months.

Kind Regards,

Sergiy 

c Carol
on January 8, 2015

Thanks, Sergiy!  I'm sure you have your hands quite full with the ambitious timelines of this is re-designed process and all the information dissemination (e.g., webinars).  You are accomplishing Herculean feats! :)

t Thierry
on January 16, 2015

Hi Carol,

I found a tweak to use the correct version of the CT when validating the define.xml: in the installation directory of OpenCDISC, replace the file "components\config\data\SDTM Terminology.odm.xml" by the one of the version you are using. At least, it allows checking that the messages you get are due to the wrong version being used.

Best Regards,
-- Thierry

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