C66736 / TINDP in 2016-03-25 version of CT

C66736 / TINDP in 2016-03-25 version of CT

In the latest version of CDISC-CT NCI code C49652  corresponds to the trial parameter "Trial Intent Type". However, in version 2016-03-25 it corresponds to "Trial Indication Type" (slight difference). In both cases the abbreviation (CDISC code) is TINDTP.

The code C66736 however does NOT correspond to a trial summary parameter, but it belongs to the complete codelist that is associated with it, i.e. containing the allowed VALUES for TINDTP being: "BASIC SCIENCE", "CURE", "DEVICE FEASIBILITY" and so on.

So, in your define.xml, you should have something like:

<CodeList OID="CL.C66736.TINDTP" Name="Trial Indication Type" DataType="text">
                <CodeListItem CodedValue="CURE">
                    <Decode>
                        <TranslatedText>Cure Study</TranslatedText>
                    </Decode>
                    <Alias Context="nci:ExtCodeID" Name="C49654"/>
                </CodeListItem>
                <CodeListItem CodedValue="DIAGNOSIS"> .........

for the possible VALUES of TINDTP

but for the trial parameter itself, you should have something like:

<CodeList OID="CL.C66738.TSPARMCD" Name="Trial Summary Parameter Test Code" DataType="text">
                ...
                <CodeListItem CodedValue="TINDTP">
                    ......
                    <Alias Context="nci:ExtCodeID" Name="C49652"/>
                </CodeListItem>
                <Alias Context="nci:ExtCodeID" Name="C66738"/>
</CodeList>

For the list of used Trial Parameters themselves

It is always a good idea to take a look in the source of define.xml (e.g. using NotePad++) or an XML editor, and to use a good Define-XML validation tool.
 

Thank you Jozef,I was…

Thank you Jozef,

I was editing the XML directly in Notepad++, but still could not resolve the error.  I am now suspecting that the real issue is that Pinnacle does not use the version of CT that I specified when setting up the validation, and defaults to the most recent.  In fact, I changed the term in a test version of the define to be "Trial Intent Type" from "Trial Indication Type" and the error went away.  I don't know if this is a bug in Pinnacle or if my configuration is faulty.  I will check on things here.

C66736 / TINDP in 2016-03-25 version of CT

When doing a define.xml validation, there still is a combobox on the right allowing to choose the CT version. Did you use it? Maybe it is ignored - I haven't tested that.
I strongly discourage to start editing the configuration files. Please take into account that the FDA uses the configuration files "as is", so even if you edit your configuration files and manage to get the error go away, the error will pop up again when the FDA validates your define.xml, as they use the original, unedited config file.

Yes, there is a dropdown box…

Yes, there is a dropdown box, and 2016-03-25 was what I selected.  Just to clarify, my test was to edit the define.xml (not the config file), so that the term matched the current version of CT and not the version used in the SDTM.  I had 2 other errors that popped up, and they were all for terms that had been updated between my version (2016-03-25) and the current version. 

Similarly, I have a DD0028 Error in the Unit codelist for "HPF"  [C67274].  This term was valid in 2016-03-25, but was retired in 2016-12-16.

try to re-install your CT file

Hi Brian, 

I suspect that your current installation of CDISC SDTM CT 2016-03-25 has some problems. Try to re-install it by uploading new file from P21 website.

https://www.pinnacle21.com/downloads/cdisc-terminology

https://www.pinnacle21.com/configuring-pinnacle21-community-validator-cdisc-controlled-terminology

Regards, 

Sergiy

C66736 / TINDP in 2016-03-25 version of CT

In good software, if a file cannot be correctly read or parsed, a pop-up message would appear, and the error would be documented in a log file.
I would suggest that you look into and edit the source code (when available), and correct/enhance this and then recompile. Well, if that is the course of the error.

Thanks.  It really seems…

Thanks.  It really seems that no matter which version of CT I pick from the dropdown list,  the most recent that I have installed is what is used in the validation.  As a test, I removed all the CT folders dated after 2016-03-25, and the false positives disappeared.