Define.xml

Description

Questions about creating and validating Define.xml

March 13, 2025

Good day team,

I have a study where the SD0061 check is firing however in the define.xml this dataset is indicated as hasnodata="Yes" with a comment of why no data is available. For submissions no blank datasets are created but does the P21 validator require the blank datasets?

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March 11, 2025

Hi everyone,

using the new engine 2405.2 I found out a new warning in define validation (define.xml v2.0) on the label of my CV domain (set as "Cardiovascular Findings" as per SEND-IG 3.1.1). Is it a bug of Pinnacle 21 or it's a problem in my CV domain, so in case in which way i can resolve it?

Thank everyone for the response

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March 10, 2025

we are in the process of converting define-xml 1.0 to 2.0. Below is the process I have used but please let me know if there is any other more automated process

1) create define.xml 2.0 using the imported data

2) import the previous 1.0 xml version to p21e and compare the differences between 1.0 and 2.0 (created using the imported data, please note this version will not have 'methods' 'comments' etc)

3) export the differences to excel file and keep the ones we need and delete the ones not needed. 

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March 5, 2025

Hi , I am getting below error when I had updated whereclause in VLM as PARAMCD EQ BMI likewise for other parameters. I tried to update but it is not getting resolved. Could anyone who had same or similar issue with the define spec be able to have your inputs or suggestion?

 

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January 30, 2025

I am just curious about the following finding:

I am using Define Standard 2.1 and correctly populated Excel Specs to generate the Define.

When applying a Comment on Valuelevel, then the corresponding Wording is displayed twice (see attached screenshot).

Interestingly, when having a derivation Method assigned on Valuelevel, this does not happen and the description of the Method is only shown once.

Within the code, the declarations seems reasonable:

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January 20, 2025

The derived variable IEDY is currently populated as 'No data' in the SDTM specification. Could you please guide us on how to include a comment to resolve the DD0134 issue for this in the SDTM specification?

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January 8, 2025

When validating the LB domain with the define.xml file, we came across a peculiar false positive for the SD1230 check in Community.

The message is "LBORRES datatype is not float when (LBCAT == 'HEMATOLOGY') @and (LBTESTCD == 'BASO' @or LBTESTCD == 'EOS') " and it references the Basophil LBORRES value being ".04".

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