Hi,
Please see rules Description.
In TS (Trial Summary) domain, populate a record
Updated correct term for country codes dictionary should be either “GENC” or “ISO 3166-1 alpha-3”
Kind Regards,
Sergiy
If the PMDA engine is run, the country code is supposed to be “ISO 3166” only. Is this an error?
P21, can you please provide a link to a formal FDA (non-P21) publication (or from another regulatory authority) where it states it must be “ISO 3166-1 alpha-3”?
I haven’t been able to find anything, not in the “standards catalog” nor in the “technical conformance guide”. But I may have overseen an FDA document.
Also, your own documentation for rule SD2244/FDAB011 says it must be either “ISO 3166” or “GENC”. It does not say anything about “alpha-3”.
But of course, only FDA publications can be normative.
Hi Jozef,
This is based on CDISC rules. For example, CG0456.
3166-1 format defines three different sets of country codes.
CDISC has reference to “ISO 3166-1 alpha-3” in their SDTM rules.
FDA uses GENC dictionary which is similar to ISO 3166-1 alpha-3 but limited to USA officially recognized entities.
Kind Regards,
Sergiy
Thanks!
Agree for CDISC rule CG0456,
but your own documentation says something else for SD2244 / FDAB011.
Also, if I look in the by the FDA published spreadsheet with the business rules, for FDAB011 it says “All trial design data should be submitted as specified in the FDA Study Data Technical Conformance Guide (TCG).”.
In the latest TCG however (Oct 2024) , I do not find any statement about this. Even the word “GENC” or “3166” do not appear.
Hi Jozef,
For FDA look at Data Standards Catalog, not TCG.
Kind Regards,
Sergiy
So, the description of rule FDAB011 “All trial design data should be submitted as specified in the FDA Study Data Technical Conformance Guide (TCG).” is wrong???
You refer to quite outdated source of information. All US governmental organizations are required to use GENC instead of other alternatives.
But Pinnacle Showing
Dear, we encounter a P21 issue like this
SD2287: Missing ONGOSIND Trial Summary Parameter and
SD2244: Invalid TSVCDREF value for FCNTRY ISO 3166
May I know how to deal with it?
