Can anyone answer this ADaM question for me? This is my first
experience trying to conform to CDISC ADaM guidelines.
I have a study that has two treatment periods. However, it is not a
crossover study. The same treatment remains in effect across the two
periods. So, do I just need to populate TRT1xx variables since there
is only one treatment? Or, do I also need to have the TRT2xx variables
to represent the second study period but set them to the same value as
the TRT1xx variables?
Bear in mind that this will be combined with other studies in an ISS
that have only one period so will not have the TRT2xx variables.
Is there any guideline on something like this?
Thanks.
Elaine Dempsey