DD0137 - Invalid variable label value - false positive?

s Sandra

on July 13, 2023

Hi,

It seems that P21 has wrong labels in its model SDTMIG 3.3:

- ECOCCUR: expects 'Occurrence Indicator' while SDTMIG has 'Occurrence' (source: SDTMIG 3.3 section 6.1.3.2)

- TSVAL1, 2, 3...: expects 'Parameter Value 1, 2 ...' while SDTMIG has 'Parameter Value' (source: SDTMIG 3.3 section 4.5.3.2)

Could this be corrected? Or do I miss something?

Thank you.

Forums: Define.xml

j Jozef

on July 26, 2023

DD0137 - Invalid variable label value - false positive?

I always wonder how such false positives can happen anyway (typing over errors when developing the software?), and why such validation tools do not use the CDISC Library API to retrieve the properties of SDTM variables in an automated way. Especially as the CDISC Library is the "CDISC truth".
But sponsors and regulators will soon move to CORE (CDISC Open Rules Engine) anyway ...

Matt

on July 26, 2023

P21

Hello Sandra, Both of…

Hello Sandra,

Both of these label examples have been updated in our most recent validation engine which is pending deployment to Community. Once the engine is made available and re-validated, DD0137 should clear for these.

Kind regards,

Matt