Invalid TSVAL value for PCLAS. TSVALCD = "N0000193912"

Matt

on August 31, 2023

P21

Hello Rasmus,   MED-RT is…

Hello Rasmus,

MED-RT is the successor to NDF-RT so the article still applies based on the most recent version of the FDA TCG section 6.5.1.1

https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources

The rule checks are only considering term values that are of the following concept types:

EPC, MOA, PE, and TC

This term value of Vaccine has the concept type of APC which is why the rule checks fire as it is not found in the set of values the rule checks consider valid. As mentioned in the description for the ticket, you noticed this as well.

https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=MED-RT&code=N0000193912

Clicking on “View in Hierarchy” provides you with a dropdown list of other vaccine terms that may be suitable.

Kind regards,

Matt

hi Matt Thank you for the…

hi Matt

Thank you for the quick answer.

So this means that APC is not allowed? Even if the vaccine is not in the list?

I would suggest adjusting the wording of the error to reflect that only part of the MED-RT codelist is usable. (just to make it clear what is happening).

Med-RT

The latest FDA Technical Conformance Guide states that "FDA maintains a list of established pharmacologic classes of approved moieties (61)", but when one clicks on the link of the reference, one gets a page https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/prescribing-information-resources that even doesn't mention Med-RT, neither does it provide a list.
So it looks as we need to submit a value from a list that is secret?

Matt

on September 5, 2023

P21

Hello All,   To see the…

Hello All,

To see the list of EPCs, on the webpage titled Prescribing Information Resources, scroll down and click on the heading "Highlights of Prescribing Information". Continue to scroll down until you see "Established Pharmacologic Class (EPC)", and click on the link in parentheses next to the text "FDA EPC Text Phrases for Indications and Usage Heading in Highlights". This is the list of EPCs that is maintained and updated by FDA.

Kind regards,

Matt

Med-RT and EPC

Thanks Matt!
Looks as the FDA has done its extremely best to hide this as much as possible.
When I look at this list (direct link: https://www.fda.gov/media/164568/download?attachment) I see some relationship with the Med-RT list (e.g. at https://evs.nci.nih.gov/ftp1/MED-RT/Archive/MEDRT_2023.07.03.txt), though the FDA doesn't even mention Med-RT, but I also see that FDA changed the casing of the class names, e.g. "Calcitonin" in Med-RT and "calcinotin" at FDA.
Once again another possible cause of confusion ...
Why the hell do regulatory authorities do not make RESTful Web Services for such lists available? We do live in the 21st century ...