Crosscheck IE - DM -> missing rule

m Manolya

on October 18, 2017

Hi,

Is there a possibility to add a new rule that cross-checks the data in DM.ARM/ARMCD with IE? Currently, there is only a rule that checks the following:

"No records for "SCRFAIL" subject are found in IE domain" -> FDAC103, SD1033.

However, we have had several cases where the subject got treated or had another ARM apart from "SCRFAIL", but had entries in IE domain. Yes, this is a data issue, but a Warning or Note would be very helpful in reviewing the data more carefully. So if there are entries in IE for a subject, then this subject should actually be a screen failure.

Please let me know your thoughts.

Best regards

Manolya

Forums: SDTM

s Sergiy

on October 18, 2017

Hi Manolya, …

Hi Manolya,

Thank you for this suggested check!

This is an interesting case. However, it may be more complicated.

There is a kind of common practice in many studies when there are few subjects who fail IE criteria, but they received a waiver and were randomized.

So, in addition to your proposed algorithm we also need to take into account a waiver information, which unfortunately is not standardized in SDTM model yet.

Nevertheless, we will work with FDA and PMDA teams to consider this check as their official business rule.

Thank you,

Sergiy

m Manolya

on October 18, 2017

Hi Sergej,…

Hi Sergej,

Thanks for your reply! If we'd have a check like this and the subjects received waivers, then we can annotate the P21 report accordingly.

Not sure where the waiver information goes to; I'd think that this comes from the sponsor after getting approval from IRB/IEC...So we could include the explanation also into the SDRG.

Thank you!

Manolya