m manabu
on

 

Hi, 

This is Manabu.

When I executed P21 community version 3.0.2 engine 1511.6 with IG 3.1.3 PMDA configuration, SD0058 message was shown.

When I executed P21 community version 2.1.3 with IG 3.1.3 PMDA configuration, this message was not shown.
I'd like to know how to manage this message.

SD0058

Best regards,

Manabu

Forums: SDTM

j Jozef
on March 28, 2020

For what variable did you get the error? That is important!
It looks as you have an SDTM variable in your dataset that is not a correct variable, i.e. it is not mentioned in the SDTM-IG nor in the SDTM model.
Such variables must (still, and unfortunably) be moved to a SUPPQUAL domain.
For example, if you define a variable VSCUSTOM, you should move that to SUPPVS, and "register" it under QNAM and the label for it under QLABEL.

Please indicate what variable the error is about, so that it can be excluded that this is a false positive.

Sergiy
on March 30, 2020

Hi Manabu, 

It is a known bug in PMDA engine 1511.6. You can document it with reference to Pinnacle 21.

The Validator incorrectly recognizes FA domain as a custom Findings domain instead of Findings About domain. Therefore, it complains about FAOBJ as non-SDTM variable and also incorrectly requires FABLFL variable (SD1044). 

Sorry for inconvenience.

Kind Regards, 

Sergiy

 

m manabu
on April 2, 2020

Dear Jozef,
 

I'm sorry for my late response.

Thank you for your comments. The value is FAOBJ, this error seems to be bug according to Sergiy's response.

Best regards,

Manabu

m manabu
on April 2, 2020

Dear Sergiy,

I apologize for my late response.

I understood it was bugs. I will add the following explanation into issue summary section in SDRG.

'The Validator incorrectly recognizes FA domain as a custom Findings domain instead of Findings About domain. Therefore, it complains about FAOBJ as non-SDTM variable and also incorrectly requires FABLFL variable (SD1044). '

Best regards,

Manabu

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