DD0136 - CV - Invalid dataset label value - SEND

m Matteo

on 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

Forums: Define.xml

Sergiy

on March 11, 2025

P21

Hi Matteo, P21…

Hi Matteo,

P21 configuration specs has a label "Cardiovascular Test Results" per SDTMIG 3.1.1 chapter tittle and many references in examples. You can consider this as P21 bug.

Kind Regards,
Sergiy

j Jozef

on March 12, 2025

DD0136 - CV - Invalid dataset label value - SEND

I would suggest that P21 uses the CDISC Library API to retrieve labels for datasets (and for variables depending on the standard and version), and not have it hardcoded in configuration files.
After all, the CDISC Library is the "CDISC Truth".

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