RACE, extensible or not?

h Hannes

on August 9, 2017

Dear Pinnacle team,

thanks for a great tool (community version)!

During a review of a SDTM data package (without define) and a P21 report based on v2.2.0 (created by different company, hence a different system in a shared enviorment (if that matters I don't know)), I noticed that the variable RACE in DM contains values other than the five currently in the CT (2017-03-31) and the message from P21 is "RACE value not found in 'Race' extensible codelist" and consequently the severity level is WARNING. When I am running the same data, same settings I get "RACE value not found in 'Race' non-extensible codelist" and ERRORs. What is Pinnicale's intention here? Extensible or non-extensible, ERROR or WARNING. Btw, I have not made any changes to the config files except adding MedDRA and CT files. Based on the CT it should be non-extensible I would assume?

Thanks and kind regards
Hannes

Forums: Troubleshooting and Problems

s Sergiy

on August 9, 2017

a short summar

Hi Hannes,

Actually, it's a quite complicated and confusing topic.

Here is a short summary:

Today P21 team considers messages for (RACE) CT as Warnings
Common practice is to follow CDISC (RACE) CT with few extended terms like "MULTIPLE", "UNKNOWN" and "OTHER" with details provided in SUPPDM
Therefore, for validation purpose we treat (RACE) as Extensible codelist.
Adding CT files from NCI website instead of utilizing P21 files will result in incorrect Error messages
Use https://www.pinnacle21.com/downloads/cdisc-terminology

Kind Regards,

Sergiy

h Hannes

on August 10, 2017

Thanks Sergiy,…

Thanks Sergiy,

after I posted my question I did some research and found the other posts. I also found the reason why we got the ERROR and the CRO got the WARNING. FDA have a link in their standards catalog pointing to the terminology maintained on the NCI page (which I have been using) so that is why we have decided it is correct to regard RACE as not-extensible. The five values currently in RACE might not be sufficient and I agree that the collected RACE values will be extended (as long as the CRF allows for missing/other/multiple etc). I think it would be a much better practice to explain this in the SDRG (that the non-extensible codelist is extended) instead of changing it from non-extensible to extensible the Pinnacle21 CDISC terminology.

Kind regards,

Hannes

l Lex

on August 10, 2017