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Multiple NARMS Trial Summary
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Manolya
on May 5, 2021
Multiple NARMS Trial Summary
If we have a study that includes sub studies - then creating multiple NARMS in the Trial Summary might be convenient. However, the P21 throws an error that only one record of TSPARMCD = NARMS is possible. Should this be updated or do we need to include all sub-study arms into one record?
SergiyP21
Hi Manolya, This is FDA…
Hi Manolya,
This is FDA rule. We cannot modify it.
I think they expect an explanation in Reviewer's Guide for any unusual stuff in your study.
Kind Regards,
Sergiy
If we have a study that includes sub studies - then creating multiple NARMS in the Trial Summary might be convenient. However, the P21 throws an error that only one record of TSPARMCD = NARMS is possible. Should this be updated or do we need to include all sub-study arms into one record?