About SD1448 Rule

Pinnacle 21 Support
1

Hi All,

This is Minji.
I validated SDTM with SDTM IG 3.3 configuration using P21C PMDA2411.0 engine and FDA 2405.2.
Rule ID SD1448 validation result was generated when LBSTRESC was “142.”. However, I think that SD1448 finding should not be generated as this value can be converted to a number.
Can you please confirm that I have misunderstood?

Thank you for your help.

Best regards,
MinJi

3

Hi MinJi,

We will tune SD1448 rule to not report cases where --STRESC values do not have digits after the decimal point.

The fix will be available in the new engine release.

Thanks for your suggestion!

Kind Regards,
Sergiy