Multiple NARMS Trial Summary

Pinnacle 21 Support SDTM
1

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?

2

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

3

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?