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.