AD0256: USUBJID value does not exist in the ADaM ADSL domain

w Wenting

on December 5, 2022

The USUBJID in BDS is actually the same as ADSL.USUBJID. However, the STUDYID of some records in BDS is different from ADSL.STUDYID because these records in BDS come from an extension study of the parent study. This is an integrated analysis of safety which includes the parent study and the extension study. USUBJID in both studies are the same and the STUDYID values of the 2 studies are different.

What makes me confused a bit is that the description of rule AD0256 does not say anything about STUDYID, but the records with issue shown (see screenshot attached) all have the STUDYID. So this rule does consider the combination of STUDYID and USUBJID, instead of USUBJID alone. Is that correct?

Attached Files

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Forums: ADaM

Trevor

on December 5, 2022

P21

Hi,You are correct that…

Hi,

You are correct that this rule searches by STUDYID, USUBJID to find matches. We don’t plan to update the rule to remove STUDYID at this time as we are waiting for CDISC to publish formal checks for integrated studies. Once they are published, we will assess all rules to make sure we consider integrated data.

For now, you can safely explain this finding in your reviewer guide if you confirm that all offending records are due to differing values of STUDYID.

Thanks,

Trevor