SDTM.TS

Sergiy

on December 9, 2024

P21

Hi,  Please see rules…

Hi, 

Please see rules Description.

In TS (Trial Summary) domain, populate a record

• TSPARMCD = ONGOSIND
• TSPARM = Ongoing Study Indicator
• TSVAL = Y or N depends of your study status

Updated correct term for country codes dictionary should be either "GENC" or "ISO 3166-1 alpha-3"

Kind Regards,
Sergiy

PMDA

If the PMDA engine is run, the country code is supposed to be “ISO 3166” only. Is this an error?

ISO 3166-1 alpha-3

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.

Sergiy

on February 20, 2025

P21

This is based on CDISC rules

Hi Jozef, 

This is based on CDISC rules. For example, CG0456. 

3166-1 format defines three different sets of country codes.

• ISO 3166-1 alpha-2 – two-letter. For example, US, JP, or DE
• ISO 3166-1 alpha-3 – three-letter. For example, USA, JPN, or DEU
• ISO 3166-1 numeric – three-digit. For example, 840, 392, or 276

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

ISO 3166

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.
 

Sergiy

on February 20, 2025

P21

Hi Jozef,  For FDA look at…

Hi Jozef, 

For FDA look at Data Standards Catalog, not TCG.

Kind Regards,
Sergiy

ISO 3166

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???

Sergiy

on February 21, 2025

P21

You refer to quite outdated…

You refer to quite outdated source of information. All US governmental organizations are required to use GENC instead of other alternatives.

Trial Summary FCNTRY Format Error (SD2244)

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