h HyunAh
on

 

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.

 

Forums: SDTM

Sergiy
on May 11, 2021

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 

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

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.