GENC COUNTRY code

Pinnacle 21 General General Discussion
1

Hi Colm,

According to the FDA data standard catalog, “Date Requirement Begins” for GENC terminlogy is 12/17/2020.

If the study began after 12/17/2020, GENC is applicable for FDA submission. And, GENC uses ISO 3166 names and code elements wherever possible, with modifications only where necessary to comply with US law and US Government recognition policy. I have yet to see a case where the GENC 3 Letter Code (FDA standard) and ISO 3166 are different.

If the data should be prepared for FDA submission, I think it’s worth double-checking country code against the GENC code.

And it has more to do with CDISC than Pinnacle21. Please refer to the LinkedIn “SDTM experts” forum (LinkedIn Login, Sign in | LinkedIn) or the LinkedIn Define-xml forum (LinkedIn Login, Sign in | LinkedIn) to hear more opinions.

2

Thanks Minji

This was my thinking, essentially that there almost in all cases no difference, it will just be the same 3 char code with perhaps rare deviations over time.

3

Hi all

With regards to variable COUNTRY, now that FDA has issued https://www.access.fda.gov/access_images/FURLS_GENC_Migration_2021.pdf

Are people still using the older ISO format or the new GENC values, I am not sure if they are 100% identical but they seem now to be two characters now and it would appear this is a recent FDA requirement that may not be followed currently.

Your thoughts ?