Invalid ARMCD SD0071

m Manolya

on February 19, 2021

Hi!

I am wondering about the error when DM.ARMCD does not equal TA.ARMCD where ARMCD is not “SCRNFAIL” or “NOTASSIGN”.

Ad per SDTMIG it is possible to only populate part of the ARM in a trial with more than 2 branching points. In that case ARMCD would not match TA.ARMCD. See section “Subject is not assigned to an Arm” in the IG and DM/SE example 7.

I don’t even know if cdisc is correct here, because the ARMCD should actually be the planned ARM. I’d think that ACTARMCD would be more appropriate to use, then the corresponding warning can be explained.

Should this error be a WARNING instead?

thanks!

Forums: SDTM

Sergiy

on February 22, 2021

P21

Hi Manolya, Some example…

Hi Manolya,

Some example would be helpful. I am confused. Are you talking about ARM or ELEMENT? If you have branching points in trial, then ARM may include all information like "Pbo-Drug A-Pbo"

Intended goal of SD0071 rule was to catch inconsistencies in spelling of ARM/ARMCD between DM and TA. Unfortunately, it's still quite common programming error in the industry,

Kind Regards,
Sergiy