AD1012A Secondary variable is present but its primary variable is not present Fires for ABLF

m Melissa

on April 27, 2021

Using Pinnacle 21 Community Version: 3.1.0 I just re-validated ADaM data and the ADaM define.xml after updating the define.xml - the data has not changed. I received a new validation message that doesn't make sense:

AD1012A "Secondary variable is present but its primary variable is not present" fired for "ABLF" (I assume for ABLFL/ABLFN as there is no variable "ABLF" present). I am using version 1.1 of the ADaM IG. Please see screenshot attached of "Details" tab of the P21 Community Validation Report.

Both ABLFL and ABLFN are present in the flagged domains and both are populated where applicable. There is no ABLF variable in any domain. How do I resolve this?

Attached Files

AD1012A.PNG

Forums: ADaM

Sergiy

on April 29, 2021

P21

What is validation engine?

Hi Melissa,

What validation engine do you use? AD1012A rule is under continuous adjustment.

Thank you,
Sergiy

b Bayer AG

on May 11, 2021

Hi Sergiy, I have the same…

Hi Sergiy,

I have the same issue using Pinnacle 21 Enterprise. Please find below the details of versions.

Standard: ADaM-IG 1.0
Data Package: ADaM-IG 1.0
Enterprise Version: 4.2.0
Validation Engine Version: 2010.1

Hope this helps.

Best regards,
Matthias

b Bayer AG

on August 13, 2021

The error message for ABLF still appears

Hi Sergiy,

The error message for ABLF still appears.

Example
Dataset: ADLB
Variable: ABLF (Ithink it refers to ABLFN)
Rule: AD1012A
Message: Secondary variable is present but its primary variable is not present
Class: Error

Generated: 2021-08-12
Standard: ADaM-IG 1.0
Data Package: ADaM-IG 1.0
SDTM CT: SDTM-CT 2019-12-20 (CDISC CT)
ADaM CT: ADaM-CT 2019-12-20 (CDISC CT)
MedDRA Version: 24.0
Enterprise Version: 4.2.1
Validation Engine Version: 2010.1

Can you please check and fix the rule for this check.

Thank you in advance,

Matthias

b Bayer AG

on October 15, 2022

The error message for ABLF still appears

Hi,

In my analysis dataset ADVS, both variables ABLFL and ABLFN exist and I still get the wrong error message from Pinnacle 21.

"Secondary variable is present but its primary variable is not present"

Example
Dataset: ADVS
Variable: ABLF (it refers to ABLFN)
Rule: AD1012A
Message: Secondary variable is present but its primary variable is not present
Class: Error

Validation Engine
P21 2010.1

Standards Used
ADaM-IG 1.1

Can you please check and update this rule.

Thank you in advance,

Matthias