Sponsor Controlled Terminology File

Pinnacle 21 Support Define.xml
1

Hi David,

The sample codelists-template.xls file provided with the Validator is used to generate codelists as part of the define.xml creation process. During validation, if a define.xml document is provided and contains codelists bound to variables present in your data, those variables will be checked against the codelists in your define.xml. This is the recommended way of performing custom Controlled Terminiology checks, as typically you are expected to provide this codelist metadata in your define.xml as part of a submission.

Creating your own external Controlled Terminology file is certainly possible, and involves using a supported input file format and custom Lookup validation rules. The format of the provided Controlled Terminology file is not necessary; we just maintain the format provided by CDISC so that users may easily drop in updates as CDISC makes changes to that file available. Going this route involves interacting with the configuration XML though, which is why using the codelists in your define.xml is strongly encouraged.

Regards,

Tim

2

Thanks Tim. Got it. I will modify the SDTM Terminlogy.txt file with our terms since we don’t use define.xml yet.

Regards,

David

3

Hello Team,

I need help creating a Controlled Terminology (CT) file that is specific to our company. I see the example file codelists-template.xls. I added my company specific terms to codelists-template.xls but it does not get referenced by the OpenCDISC program when I run it . Instead the file the program points to is SDTM Terminlogy.txt. This file has a completely different columns. I am having trouble understanding the purpose of having codelists-template.xls if it cannot be referenced by OpenCDISC.

Can you guide me through the steps to create a sponsor specific CT file.

Regards,

David