t Tathoum


Hi everyone,

I generated a Define.xml based on a specification sheet in excel with the P21 Validator. Then, I validated SDTM datasets with the Define.xml. The P21 report has several findings about values not defined in the codelist. In fact, those values are in my specification sheet but they are not present in the code of the define.xml. I then assume that something went wrong when my excel file was read-in by the P21 tool to generate the define.xml.

Any idea how I could solve this issue?

Many thanks

Forums: Define.xml

j Jozef
on February 17, 2022

As a last resource (but really last resource), you can always edit the define.xml file manually using an XML editor or NotePad++, and add the values yourself.
Avoids you to have to go through multiple cycles of trial-and-error.
There are also GUI based Define-XML builders and editors on the market that work with WYSIWYG (what-you-see-is-what-you-get).

t Tathoum
on February 18, 2022

Hi Jozef,
I agree with you, updating the define.xml is the last option I wanted to do. It implies that each time we generate the define.xml, we have to manually update it. Moreover, it is not really traceable...
I would like to work with GUI, unfortunately, it is not the company's policy at the moment...
Any idea what could cause the issues?

Many thanks!

j Jozef
on February 18, 2022

I do have some ideas why the issue occurs, but will need a bit more details from you.
You can always contact me by e-mail.

on February 21, 2022

Hi Tathoum, 

Could you share your excel specs for diagnostics of this issue?

Thank you,
sergiy at pinnacle21 dot com

on February 22, 2022

Hi Tathoum, 

I tried to replicate your case and found a bug in P21 Define.xml Generator.

It looks like "Codelist" table should be sorted before generation of define.xml file. For example, if specifications for some codelist are split into 2 blocks separated by specs of other codelists, then only terms from the latter block of specs will be included into define.xml file.

See attached example. For CMCAT codelist, terms TEST1 and TEST2 will be present in define.xml, while terms like PSYCHOTROPHIC DRUG TREATMENT HISTORY will be skipped.

So, if your issue related to this bug, then a simple temporal solution is to sort "Codelists" table by ID prior generation of define.xml file.

Sorry for inconvenience and thank you for helping with identification of this bug! You are the first person who hits this issue since 2010. ;)

Kind Regards,

Example of split specs for a codelist


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