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Started: 1/16/2018 4:12 AM
Populating AEACN

When is it appropriate to use N/A or DOSE NOT CHANGED?

Is this question designed to be answered based on the current study drug the subject is taking?  If so does that mean:

1. All Pre-dose AEs = N/A as there is no dose to chage?

2. All AEs that occur between sessions = N/A as the treatment the subject took during session 1 can not be changed and teh treatment in session 2 has not yet begun?

 

Or alternativley do you answer this question basd n teh whole study?

1. Only use N/A after last dose?

This is sometign I have had many internal discussions about and no one can give me a concrete answer.

Any hlep much appreciated.

Posted: 7/4/2018 1:53 AM
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