Hi HyunAh,
It does not matter. Screen Failures are still Screen Failures. Value for ARM variable should be as for Screen Failure depends on requirements form specific Regulatory Agency (e.g., FDA or PMDA) and version of SDTM you use.
Kind Regards,
Sergiy
We have a patient who did not meet inclusion criteria but was randomized mistakenly, and we will treat the patient as "Screening Failure".
I understood that ARM variable in SDTM should consist of planned arm (assigned to through randomization).
For this case of SF patients who proceeded randomization mistakenly, which data (treatment group randomized vs. 'Screen Failure' vs. blank) should be filled in ARM variable?
Please consider that this case is not same with the case of patients who are randomized in treatment group but not treated.