Check SD0040: Inconsistent Testcodes for the same Test

r Reema

on August 29, 2013

Hi All,

The check SD0040 only checks for inconsistent test names against same test code. Does it also check if 2 different testcodes use the same Test name?

This contradicts to what ADaM rule says, as per ADaM rule, AD0142, for a given value of Parameter name (PARAM), all values of Parameter code (PARAMCD) should be the same.

We have seen this case in one of our trials, where 2 different questionnaire panels use the same QSTEST for 2 different QSTESTCD with different QSCAT. And the Open CDISC does not throw any warning message when run on final SDTM output.

As we create ADaM from SDTM, this results in a discrepancy.

Please suggest what shall be the next steps for this case.

Forums: SDTM

s Sergiy

on September 3, 2013

Hi Reema, Could you provide

Hi Reema,

Could you provide examples? I could not find any inconsistencies in 1:1 relationship between QSTEST/QSTESTCD terms in the current CDISC QS Terminology.

Thank you,

Sergiy

r Reema

on September 3, 2013

QSTEST/QSTESTCD mismatch

Hi Sergiy,

We have not been using CDISC QS terminology for our current studies. I agree that this will hold true if we adopt the QS terminology.

But for now what we saw was 2 different questionnaire panel (CGI score, in Severity and Global Impression) had used same labels for 2 different items. So, in SDTM it appears with 2 different QSTESTCD but same QSTEST. And Open CDISC did not show any warning message for this.

As we use SDTM to build ADaM, it did come up as a warning for the analysis datasets. Hence, I raised this question. For now, we just left it as is.

Thank you for your time.

Regards,

Reema

s Sergiy

on September 3, 2013

It's a bad practice. I would

It's a bad practice. I would highly recommend to create/keep an unique code for each question/test name across all questionnaires, lab categories, etc.

Regards,

Sergiy

r Reema

on September 3, 2013