These are exceptions because there are already rules which would trigger issues when those variables are not populated. The idea is to not raise multiple errors for same logical issue. Because TRTA is not required, i do not list TRTAN as an exception because if TRTAN is a numeric description of TRTA, then you better include the variable you are describing numerically. Does this make sense ?
Thanks Michael.
TRTP/N and TRTA/N have the same kind of function, i.e. to describe the treatment. If TRTP is required and TRTA is conditionally required, that's not relevant for the purpose of this issue.
For a crossover study when a record is not treatment period related, you could choose different approaches, one of them and I can recognize maybe it's not the best one is to set TRTPN=99, TRTP null, TRTAN=99 and TRTA null. I think it doesn't make sense to get an error for TRTA/N but not for TRTP/N.
It's possible because TRTP is required, i thought AD1008 would fire when it's null and that's why i excluded it from AD1011. But not all required variables in ADaM need to be populated such as TRTP. Perhaps the exclusion of TRTPN should be removed so that when it's populated, TRTP should be populated. Then it would match TRTA/N
I see. What is the use case for having only TRTPN and TRTAN ? The guide says that "N" is the numeric representation of TRTP/A. So wouldn't you need to have the original character representation too ?
Dear all,
As mentioned here already, ADaM variables considered as 'Required' does not mean they should be populated.
So for the error to fire in case of presence but not being populated while the secondary variable is populated, TRTP, TRT01P, and PARAM should be removed from the list of exceptions.
Can this adjustment be made in any of the following releases?
With regards,
Jeroen