System Organ Class --SOC should not be checked to be in UPPER CASE

Yes, it's a well-known and

Yes, it's a well-known and old inconsistency between CDISC SDTM IG, Terminology and MedDRA dictionary.

E.g., see http://www.opencdisc.org/forum/ct0037-errors-meddra-soc-terms-sentence-case-format

It's good news, that the CDISC Terminology team is finnaly ready to fix it.

Thanks, 

Sergiy Sirichenko

CT0037 --BODSYS check is still active but not relevant

Hi,

This check in the Amendment 1 configuration is still firing for these variables, even using the updated config versions for OpenCDISC.  It shouldn't happen because the CDISC SDTM codelist for C66783, for System Organ Class, has been completely retired/removed for some time now. So this check is not needed. 

It seems now the check to replace CT0037 and apply to --BODSYS should be more like the recent rule SD2015 you have for the --SOC variable.  Both of these variables --SOC and --BODSYS should be checking against the external MedDRA list of values for system organ class.

CT0037 is a holdover for some earlier terminology lists.

Thank you!

Joan

Hi Joan,  You are completely

Hi Joan, 

You are completely right. However some sponsors can use older versions of CDISC Terminology and SDTM.

Starting SDTM 3.1.3 (or even Amend 1) expected codelist for --BODSYS variables is from MedDRA dictionary.

We have adjusted our old and new profiles to handle this issue.

Thank you, 

Sergiy

Test of profile?

Hi,

Thanks Sergiy. 

You wrote you have adjusted the old and new profiles to handle it.  However, testing now using the file config-sdtm-3.1.2-amend-1.xml from the latest (revis. 1090) version shows no change/ improvement.

Can you advise?  Thank you!

Joan

SDTM Terminology Fixed.xml, newest

  --  still maintains codelist  C66783.  Is that what makes the problem persist?  Since this is a known discrepancy of case, would an ignore-case modification to the (persistent) check against the SDTM controlled-term be a very simple fix?

Joan

Hi Joan, Sorry, but you are

Hi Joan, 

Sorry, but you are using quite outdated file (2012-07-10) for your testing. In current under development profiles CT0037 check is replaced by SD2017 check (similar to SD2015) as you suggested.

Also Amend 1profile will be not included in the upcoming release. It will be replaced by 3.1.3.

Thank you,

Sergiy Sirchenko

Thanks, and looking forward to the profile in the next release

It will be a big help.