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--SOC and --BODSYS CT checks incorrectly expect all uppercase
Forums: Troubleshooting and Problems
Hi Carol, I am a little
Hi Carol,
I am a little confused. CT0037 check is not present in SDTM 3.1.3 profile. Could you confirm that you have it in your validator package? I believe that we removed CT0037 check completely from all SDTM profiles in v1.4. It was done before CDISC drop the (SOC) codelist from SDTM CT.
SD2015 check is case-insensitive and produces an Error when a term is not present in MedDRA regardless of character case usage.
SD2015C check is case sensitive version of SD2015 check. It generates Warning messages when the only difference between a data value and a MedDRA term is related to incorrect case.
Thank you for your feedback. Could you provide any additional details on this MedDRA/CDISC CT issue?
Kind Regards,
Sergiy
It may relate to this bug-fix at the //svn site
Sergiy,
The official new release of OpenCDISC 1.4 was giving unwarranted error like Carol described: "Value for --SOC not found in MedDRA dictionary", and it showed "SD2016" as rule name instead of SD2015 -- when tested with the MedDRA dictionary attached. So you responded and fixed those problems with the //svn version, with link given here:
http://www.opencdisc.org/forum/sd2016-meddra-checks-aesoc-opencdisc-14#comment-924
Please make sure this fix remains in the next official release and doesn't slip back - since sentence case for the SOC is truly the correct MedDRA case that FDA expects.
Thank you,
Joan
Using OpenCDISC 1.4, config-sdtm-3.1.3, and CDISC CT 2013-04-12, the following 2 errors are generated when system organ classes in the data are in sentence case as they exist in the MedDRA dictionary:
CT0037 Value for --BODSYS not found in (SOC) CT codelist
SD2015 Value for --SOC not found in MedDRA dictionary
It appears that OpenCDISC uses an all uppercase version of the terms instead of the sentence case used in the MedDRA dictionary. SDTMIG version 3.1.3 section 4.1.3.2 instructs “If the external reference for the controlled terminology is not in upper case then the data should conform to the case prescribed in the external reference (e.g., MedDRA and LOINC).”.
CDISC has removed the SOC CT codelist entirely from their file. Therefore, I’m guessing OpenCDISC may still have some lingering hard coding of the SOC terms incorrectly in all uppercase.