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

Pinnacle 21 Support SDTM
1

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

2

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

3

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

4

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

5

– 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

6

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Sorry, but you are using quite outdated file (2012-07-10) for your testing.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

7

It will be a big help.

8

The upper case list of SOC values in the CDISC controlled terms file has been problematic and it is known to be at odds with MedDRA SOC, which is truly sentence case, e.g., Metabolism and nutrition disorders

The CDISC terminology work group has recognized the conflict and stated they intend to deprecate the SOC list from the terminology list in terminology Package 10; the SOC values can be found instead in the MedDRA dictionary. Therefore, the OpenCDISC check for all caps, and the warning message, is excessive.

Thanks,

Joan