h Hariprasath
on

 

Hi All,

I have gone through the forum for this issue. There are responses in general saying that Epoch would fit between visit variables and date variables. So this is the order I have currently:STUDYID DOMAIN USUBJID VISITNUM VISIT VISITDY EPOCH SVSTDTC SVENDTC SVSTDY SVENDY. But I still receive the warning from P21. Please let me know what would be the correct order of these variables in SV. Thanks for your help

 

Forums: Define.xml

j Jozef
on August 27, 2019

I am of the same opinion as you are. In my own software offerings, "EPOCH" always comes between the "VISIT" variables and the "DTC" (date/time) variables.
DON'T change the order of the variables to satisfy any validator messages when you think you are right. Better document the validation message in the "Reviewers Guide" - also reviewers read this forum ...

Sergiy
on August 28, 2019

Hi Hariprasath, 

Jozef is correct. You should follow formal standard or regulatory guidance first. Validator helps you. However, sometimes there are bugs in software.

Nevertheless, you are expected to receive validation message in your case. Validation specifications are the same as your actual data.

Could you provide more details about your case. What is a version of Validator, standard name and its version? What rule do you refer? 

I assume that you utilized an outdated version of Pinnacle 21 Validator.

Kind Regards, 

Sergiy

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