SD1083: Missing DY variable for screening failures in DS

Pinnacle 21 Support SDTM
1

Hi Marianne,

Yes, it’s OK and expected to have missing values for Screen Failures in Study Day variables like --DY, --STDY, --ENDY.

The SD1083 check looks for a presence of --DY variable. It assumes that at least some study subjects are not Screen Failures and have populated RFSTDTC variable values.

The SD1086 check (for correct calculation of --DY value) works only if both RFSTDTC and --DTC variables values are not missing and have full Date part.

In new upcoming version of the validator, checks around expected Study Day variables will be removed from Inclusion/Exclusion domain because in most cases this domain includes records only for Screen Failures.

Kind Regards,

Sergiy

2

For the screening failures a disposition date (DSDTC) may exist, but since the DSSTDY is calculated based on reference date (RFSTDTC) from DM, which is missing for screening failures, a warning is issued.

I think it should be ok to have a missing DSSTDY for screening failures.

KR Marianne