Can Codelist for ETHNIC variable use "ETHNICC"?

z ZHOU

on July 27, 2022

The Controlled Terms of ETHNIC in IG is "ETHNIC", I noticed that there is a code of "ETHNICC" in the 2022-06-24 version of CDISC SDTM Controlled Terminology, can I use this code here?

Forums: SDTM

Sergiy

on July 28, 2022

P21

Hi Zhou, CDISC SDTM CT…

Hi Zhou,

CDISC SDTM CT codelist (ETHINC) is designed for FDA. So, for FDA submissions, you have to use this codelist and keep additional more granular information like "Ethnicity as Collected" in SUPPDM dataset if needed.

For other regulatory agencies, I would recommend to contact them for clarification. For example, (ETHINCC) codelist includes 56 terms for Chinese-specific ethnicity which may be valuable for NMPA review.

Kind Regards,
Sergiy

P.S. However, I am not sure about sense of English terms for NMPA submission.