P21 label does not match SDTM 3.2 IG

l Lisa

on May 15, 2022

The following variables and labels reported as issues in P21 do not match the SDTM 3.2 IG:
PPSTRESC IG="Character Result/Finding in Standard Format" P21 Config=“Result or Finding in Standard Format”

PCSTRESC IG="Character Result/Finding in Standard Format" P21 Config="“Result or Finding in Standard Format”

Thanks,

Lisa

Forums: Enhancements and Feature Requests

Sergiy

on May 24, 2022

P21

Hi Lisa, Some variable…

Hi Lisa,

Some variable labels in CDISC SDTM-IG documentation are not valid. For example, label for PPSTRESC is 43 characters long. It exceed limitation of 40 chars in SAS XPORT v5 format. You cannot implement it in your datasets for FDA/PMDA submission. Therefore, in P21 specs we replaced invalid labels by generic labels from SDTM Model.

We are still considering other options. For example, just strict compliance to SDTM-IG. For example, "Character Result/Finding in Standard For" as first 40 chars from SDTM-IG.

Kind Regards,
Sergiy