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ADaM question   Message List  
Reply | Forward Message #274 of 330 |
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






Thu Oct 30, 2008 5:35 pm

elaine_d_1998
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Message #274 of 330 |
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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...
Elaine
elaine_d_1998
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Oct 31, 2008
10:20 am

Elaine, We have the ADaM gurus in our user group ;-), so you should be able to get a clear answer but I will take a shot. This is based on our experience ...
Chris Decker
chris_decker71
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Oct 31, 2008
2:22 pm

Dear Elaine, The response by Chris is nearly accurate. One of the primary principles of ADaM is clear communication about the analysis that was performed for ...
Susan Kenny
sjkenny_cdisc
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Nov 10, 2008
4:39 pm
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