FDAC033- SDTM/dataset variable label mismatch

Pinnacle 21 Support SDTM
1

Hi Priyanka,

What is SDTM version your refer to?

For example, in SDTM IG 3.2 a label for ECPRESP should be “Pre-Specified”. In SDTM IG 3.1.3, EC is not standard domain, so Validator treats ECPRESP as variable of Custom domain and compares its label with generic Description from SDTM Model as “Pre-specified”. In the second case P21 Validator generates Informational message rather than Warning.

Kind Regards,

Sergiy

2

Hi,

I am validating with IG version 3.2 and the label of the variable is provided as “Pre-Specified” as per IG.

Any suggestion for the below issue?

PESTRESC, Character Result/Finding in Std Format

3

Hi Priyanka,

  1. P21 specs refer to “Pre-Specified” label for ECPRESP variable. There are no other reports about false-positive messages in this case.

It could be something wrong with your variable label. For example, a use of dash character (Pre–Specified) instead of hyphen (Pre-Specified).

  1. SDTM IG 3.2 has invalid Label for PESTRESC variable. Its length is 43 characters.

You modified it to fit a 40-character limit.

We did a similar adjustment. In Pinnacle 21 Community 2.2.0, all invalid variable labels were replaced by “generic” labels from SDTM Model. For example, SDTM IG 3.2 label for PESTRESC “Character Result/Finding in Standard Format” was replaced by “Result or Finding in Standard Format”.

It’s not a perfect solution. We are considering different options. For example, ignoring validation of invalid SDTM IG variable labels.

Kind Regards,

Sergiy

4

Hi,

Why do we get warnings on in Pinnacle report the variable label mismatch?

ECPRESP, Pre-Specified

PESTRESC, Character Result/Finding in Std Format

What should be the Label ?