SD2263: Invalid TSVAL value for PCLAS

Pinnacle 21 Support SDTM
1

Hi Priyanka,

You use a term which is not from component concepts supported by FDA for submissions. (Additional Pharmacologic Classes [APC] )

Please see details at https://www.pinnacle21.com/forum/sd2264-invalid-tsvalcd-value-pclas.

Kind Regards,
Sergiy

2

We are using MED-RT 2022-07-05 for TSVAL/TSVALCD for PCLAS and the values are there within the dictionary but I’m still getting the following issues:

SD2263: Invalid TSVAL value for PCLAS## SD2264: Invalid TSVALCD value for PCLAS## SD2265: TSVAL/TSVALCD value mismatch for PCLAS

TSVAL = Immunologic Agent

TSVALCD = N0000193902

Not sure why these are being flagged when I can see them within the dictionary. There were no leading or trailing spaces. I’ve tried with and without the parenthesis.

Thank you in advance.