DD0028: Term/NCI Code mismatch in Codelist 'Unit'

Pinnacle 21 Support Define.xml
1

One obvious error I immediately see is the “OrderNumber” attribute on CodeListItem. This attribute is not allowed to be present.
I haven’t tested however whether that is the cause of the DD0028 error.

2

OrderNumber is actually allowed on the CodeListItem element. It was introduced in ODM 1.3.2 that came with Define-XML 2.0. Also, I’m not sure whether it is causing the issue, but I would not expect to see multiple values in the Decode/TranslatedText. These are multiple aliases separated by semi-colons.

3

Thank you for remembering me Lex! OrderNumber is indeed allowed. I made an error. My apologies!
I just did a test with a define.xml file with "OrderNumber"s on CodeListItem, and it does not cause the DD0028 error. So it must be something else.
So I checked the NCI codes C67376 and C48542 and they both seem to be OK (I used the CDISC-CT RESTful web services at XML4Pharma Web Services), returning “IU/L’” and “TABLET”. Also the code “C71620” for the “UNIT” codelist is correct.
As Lex stated, I also would not expect multiple values in the Decode/TranslatedText, so I also I did a test on that in a test file, and I did not get a DD0028 error either.
So I copied Daisuke’s XML snippet into a test file and tested different scenarios, but could not reproduce the reported issue, at least not when using Validator v.2.1.3 with CT version 2017-09-29.

Daisuke, do you get the same error when selecting another version of CDISC-CT? That would make it easier to track the cause …

Please also take into account that everything in XML is case sensitive, and so are the codes and NCI codes. Also a trailing blank can be “deadly” or a problem with character encodings.

4

Hi,

Thank you very much for your prompt comments.

When I used other version of CT (2017-06-30) and other version of PINNACLE21 (v2.2.0), I got same issue.

Thanks, Daisuke.

5

If you want (and are allowed to do so), you can always send me the file, so that I can use some of my “special” tools to find out what the cause is.
I suspect a trailing blank or a character encoding problem or something minor that is not obvious at first sight.

6

Hi Daisuke,

NCI Code C67376 represents different terms in (UNIT) and (PKUNIT) CDISC CT: "IU/L" and “mIU/mL”.

You may get DD0028 message if you utilize your codelist for PPORRESU or PPSTRESU variables.

Kind Regards,

Sergiy

7

Hi,

I am getting the warning message DD0028 for some codes in Codelist “Unit”.

Examples are below :

IE/L; IU/L; International Unit per Liter; mIU/mL Tablet Dosing Unit; tab

How should I resolve this issue ?

PINNACLE21 Community 2.1.3, Define.xml (PMDA) config, Controlled termnology version 2017-09-29

Thanks, Daisuke