h Hyewon
on

 

 

 

As per protocol , Eligibility criteria confirmation is done at V1 (screening) and at V2(Day1 of treatment epoch, before randomization.)

In case Eligibility criteria was all met at V1, but not met at V2 so that ends in Screening Failure, 

Can I assign epoch as 'SCREENING' to V2 while Randomized Patients are assigned as 'TREATMENT' at V2?

I mean, Doesn't  Visit and Epoch have to match 1:1?

Please help me to get assurance. 

 

 

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