SDTM-IG 3.3: DSDY is expected variable?

a Anton

on April 26, 2021

Hi Team!

Could you please explain the next confusing validation?

As per SDTM-IG: DSDTC is permissible while DSDY is expected variable, DSSTDTC is expected while DSSTDY is permissible. Seems that the core value for DSDY and DSSTDY is mixed up since there is no sense to present DSDY (expected) when DSDTC (permissible) is not presented in SDTM.DS and vice versa for DSSTDY/DSSTDTC variables. I see that Pinnacle the same logic. In this case, validation issue SD0057 will be a frequent visitor in the validation report. Do you think it will be correct to follow the guide's logic of guide 3.3 in this case?

With regards,
Anton

Forums: SDTM

Sergiy

on April 26, 2021

P21

Hi Anton, Pinnacle 21…

Hi Anton,

Pinnacle 21 validator is based on official specs published by SDOs (Standard Development Organizations). We were highly criticized every time when corrected obvious errors in official documents.

Historically CDISC does not correct errors in their published standards. Few years ago, they introduced Errata pages on the website. For exampe, https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-v3-3

However, your issue is not in the list.

Kind Regards,
Sergiy