For our study we need to keep some parameters from source SDTM dataset and some derived parameters in ADaM dataset.
But baseline variables BASE,BASEC,ABLFL are only needed for derived parameters. Is it okay to have them populated for few parameters and missing for most in the adam dataset?
We do have the Validation rule AD0127 "Within a given Subject's PARAMCD, a baseline value is populated (either BASE or BASEC) and there is not at least one record in that group marked as the baseline (ABLFL = Y)." . But no rule for consistency of values within a dataset accross different paramcd. Hence, I do not really see any error/warning in this scenario. Could it be possible to clarify?
Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.
For our study we need to keep some parameters from source SDTM dataset and some derived parameters in ADaM dataset.
But baseline variables BASE,BASEC,ABLFL are only needed for derived parameters. Is it okay to have them populated for few parameters and missing for most in the adam dataset?
We do have the Validation rule AD0127 "Within a given Subject's PARAMCD, a baseline value is populated (either BASE or BASEC) and there is not at least one record in that group marked as the baseline (ABLFL = Y)." . But no rule for consistency of values within a dataset accross different paramcd. Hence, I do not really see any error/warning in this scenario. Could it be possible to clarify?
Thanks a lot.
Gehana.