SD1151 / FDAB009

e Elizabeth

on January 31, 2023

When the Inclusion/Exclusion criteria do not change, but a new one is inserted in a subsequent version, the criteria number has been identified by adding a suffix to the IETESTCD.

TIVERS=Version 1

IETESTCD=EXCL01

IETEST=Ongoing infection

TIVERS=Version 2

IETESTCD=EXCL01A

IETEST=Patients with melanoma

IETESTCD=EXCL02A

IETEST=Ongoing infection

Pinnacle 21 however gives the following message for the EXCL02A record, since the same IETEST now has two different IETESTCD.

Inconsistent value for IETESTCD within IETEST

With further explanation:

FDAB009:

All values of Inclusion/Exclusion Criterion Short Name (IETESTCD) should be the same for a given value of Inclusion/Exclusion Criterion (IETEST).

I believe this business rule should exclude the TI domain for this reason. The criteria number must be reference in IETESTCD, or there is no way to link it to the CRF/Protocol/Data entry value. This rule should be for IETEST within a TIVERS.

Forums: SDTM

Sergiy

on February 2, 2023

P21

Hi Elizabeth, SD1150 and…

Hi Elizabeth,

SD1150 and SD1151 rules will be updated in the next Engine release by adding TIVERS variable as shown in your example.

Kind Regards,
Sergiy

e Elizabeth

on February 2, 2023

Thanks Sergiy, that's great…

Thanks Sergiy, that's great. I think, however, that SD1150 is correct without TIVERS. The SDTM IG makes it clear that a different exclusion criteria (IETEST) should have a different code (IETESTCD), which is why my example includes a suffix.

Elizabeth

Sergiy

on February 2, 2023

P21