COVID-19 Interim User Guide

Pinnacle 21 General General Discussion
1

Hi David,

Thank you for bringing attention to this important topic! Implementation of COVID-19 guidance and CDISC UG is under discussion by Pinnacle team.

Kind Regards,
Sergiy

2

Will Pinnacle 21 Community be including validation rules that support the FDA Guidance on conducting trials during the COVID-19 Pandemic and the CDISC COVID-19 Interim User Guide? For example, will there be validation of the VE domain and it’s relation with the SV domain.