j Joan
on

 

The new validator seems to have a check for the SOC Code (SD2016) being run against the SOC Text variable.

This is what I've encountered.  I've put a copy of the MedDRA dictionary files in the \data folder for the 1.4 validator, and now reran the new validator with the MedDRA files (and no define.xml).  It is possibly a validator mixup, not solved from earlier discussions, of misfire for AESOC when the values are in the correct sentence case, matching MedDRA. But the report cites SD2016, with message description about --SOCCD, even though the value being checked is the SOC, not the code.  Severity: Error. 

Note, the "SDTM Terminology Fixed.xml" file under \data in the new release version still contains the SOC controlled term list (and SOC is no longer a CDISC maintained CT list); however, I don't know if it is that file that is causing the issue.

As an example  - the OpenCDISC report shows Variables:  "AESOC", Values: "Gastrointestinal disorders", ruleid SD2016, "Value for AESOC not found in MedDRA dictionary."  Yet the Rules tab shows that SD2016 is for the SOCCD values, not SOC. Similar validation message is issued for every single data record in the AE dataset.

This dataset was also checked with validator 1.3, and no error noted for the SOCCD values (it only had that stubborn issue of the sentence case). 

Please check the application of SD2016 for AE terms.  Thank you very much.

- Joan

Forums: SDTM

s Sergiy
on March 22, 2013

 

Hi Joan, 

This bug was fixed.

As a temporary solution you can download a development version of a SDTM 3.1.3 config file at

http://svn.opencdisc.org/validator/trunk/config/

Thanks, 

Sergiy

 

j Joan
on April 15, 2013

Best,

Joan

m Méhadjia
on July 16, 2013

Dear Sergiy,

I have the same problem as Joan. And saw your answer and I tried to copy the following files at the link that you said

  • config-adam-1.0.xml
  • config-define-1.0.xml
  • config-sdtm-3.1.1.xml
  • config-sdtm-3.1.2.xml
  • config-sdtm-3.1.3.xml
  • config-send-3.0.xml
  • and I coudn't. Impossible to open them. So my question is, Can I keep the existing files on the OpenCdisc v1.4 only for those files above ?Thanks,

    Regards,

    Méhadjia.

    s Sergiy
    on July 16, 2013

    Hi Méhadjia, 

    You used wrong location of files. You need the SDTM 3.1.3 config file only.

    http://svn.opencdisc.org/validator/trunk/config/config-sdtm-3.1.3.xml

    Kind Regards,

    Sergiy 

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