SDTM 3.2 IG PINNACLE MESSAGE

r Radhika

on December 18, 2024

I am getting below mentioned issue related to the model permissible Reference Range variables i have added in Vital sign domain but the label for the variable is going correct. how to resolve this issue are there any other labels present

VSORNRHI, Reference Range Upper Limit in Orig Unit SD0063A SDTM/dataset variable label mismatch

VSORNRLO, Reference Range Lower Limit in Orig Unit SD0063A SDTM/dataset variable label mismatch

VSSTNRHI, Reference Range Upper Limit-Std Units SD0063A SDTM/dataset variable label mismatch

VSSTNRLO, Reference Range Lower Limit-Std Units SD0063A SDTM/dataset variable label mismatch

Forums: SDTM

j Jozef

on December 18, 2024

SDTM 3.2 IG PINNACLE MESSAGE

SDTMIG-3.2 is based on SDTM model 1.4.
So if VSORNRHI is not in the IG, you need to look into the corresponding model, which in your case is 1.4.
For --ORNRHI in SDTM model 1.4, the label is "Normal Range Upper Limit-Original Units".

Please start learning how to use the CDISC Library: there you can find the anwers to such questions in less than a minute!
For example, in your case, use: https://library.cdisc.org/browser/#/mdr/sdtm/1-4/classes/Findings

Using the CDISC-Library API, you can also automate such processes.

Sergiy

on December 26, 2024

P21

Hi Radhika, First of all,…

Hi Radhika,

First of all, Labels for "Model Permissible" variables are not 100% rigid. You may have an option to modify them if needed for more clarity of your data interpretation. That's why our SD0063A rule is a Notice, rather than a Warning (SD0063).

As a reference P21 Validator uses Variable Labels from SDTM v1.4. In your case expected Labels are

VSORNRLO - Normal Range Lower Limit-Original Units
VSORNRHI - Normal Range Upper Limit-Original Units
VSSTNRLO - Normal Range Lower Limit-Standard Units
VSSTNRHI - Normal Range Upper Limit-Standard Units

As an alternative to CDISC Library, you can use P21 configs files used for validation. In default installation, you can fins them in <Users>\Documents\Pinnacle 21 Community\configs\<engine> folder. For example, "SDTM-IG 3.2 (FDA).xml". P21 validation configs are an extension of Define-XML format. So, look for ItemDef element or simply search for variable name (ItemDef is the second search case after ItemRef).

Kind Regards,
Sergiy