FDAC341 (Variable value not found in extensible codelist)

r Rohit

on November 30, 2017

"FDAC341 (Variable value not found in extensible codelist)" check is not being performed unless a define.xml is loaded. Is there a reason for that? It can theoretically be done without a sponsor define.xml e.g. EGTEST has the CT of EGTEST specified in SDTM 3.2 and hence EGTEST codelist can be used to do this check.

It is a useful check to have prior to generation of define.xml since it would catch the problems earlier.

Forums: SDTM

s Sergiy

on November 30, 2017

Could you provide more details?

Hi Rohit,

I cannot reproduce your case. Could you provide more details? Versions of Validator, CT, SDTM configs, etc.? What variable and terms are involved?

Thank you,

Sergiy

j Jozef

on December 1, 2017

FDAC341 Define.xml

Dear Rohit,
It is very good practice to already generate your define.xml even before your study starts. Generating it post-SDTM should only be a "last resource" practice.
Please take into account that the define.xml represents the "Sponsors truth".

r Rohit

on December 1, 2017