SD1124: missing value for xxREASND when xxSTAT is NOT DONE

Hi Cathy,  You are correct.

Hi Cathy, 

You are correct. --REASND is not conditionally required variable. 

I still think that a such check could be useful, but I am not sure about its best implementation.

Could you confirm, that you populate --REASND only for some 'NOT DONE" records? Usually a decision to collect or not "Reason for not done" info is a part of CRF design. If you decided to collect, then you expect to collect. If you do not care, then you decide to not collect and --REASND variable is not in study data. The discussed check will ne not executed.

We definitely need to discuss the SD1124 check in more details.

Thank you for bringing the attention for this subject!

Regards, 

Sergiy

Hi Sergiy, Yes there may be

Hi Sergiy,

Yes there may be cases where xxREASND is populated for some NOT DONE records, and not populated for other NOT DONE records.  For example, xxREASND may be collected for one lab test (reason pregnancy test was not done), but not collected for all tests, so even though the variable exists in the dataset, it was not actually collected for all the data in the domain.     

Cathy

Followed SD1124 discussion

Hi P21 teams,

May I follow the discussion raised by Cathy?

Just like above discussion, lots of CRF design collected the overall reason if subject not performed assessment and not collected the separated test not done reason.

Usually, we mapped the test code into "--ALL" and reason into --REASND if subject not performed the whole assessment.

Separated test didn't collect the not done reason, but we still mapped the --STAT into "NOT DONE".

Chris

Sergiy

on February 2, 2023

P21

Hi Chris,  This rule will…

Hi Chris, 

This rule will be removed in the next engine. SD1124 (Missing value for --REASND, when --STAT is 'NOT DONE')

Kind Regards,
Sergiy

Hello Sergiy,   Thank you…

Hello Sergiy,

Thank you for sharing, do you have any source for this information and timelines? 

I hope CDISC and FDA will communicate soon bout this change as it will ease the work for many of us dealing with this check.

Kind Regards, 

Assia

Hello Sergiy,Recently, I…

Hello Sergiy,

Recently, I validated data via FDA 2304.03 engine, and the validation rule was truly removed. However, there is no newer version of FDA validator rule than v1.6. May I confirm if CDISC has communicated with FDA on the removal of validation rule. Thanks. 

Best Regards,

Hugh