NA to Error/Warnings for FDA/PMDA

Pinnacle 21 Support SDTM
1

Well, is VSORRES can be null (empty), due to “NOT DONE”, either at variable or value level, than you should set Mandatory=‘No’ in the define.xml isn’t it?

2

Hi Abin,

For questions related to Enterprise version, please use our P21 Enterprise support resources.

Kind Regards,
Sergiy

P.S. I agree with Jozef’s answer.

P.P.S. There is recently introduced new version of PMDA rules which now include SD1229

3

Hi,

I recently noticed few rules has changed from NA to Error/Warnings in Pinnacle 21 Enterprise Validation Report. Example SD1229 - Variable value must be populated when value level attribute Mandatory=‘Yes’ as specified in define.xml file. How we can populate xxORRES variable when its a NOT DONE record?

Thanks

Abin