Bioequivalence and Bioavailability Forum

Hi all,

Sort of a strange question but what are considered as enrolled subjects? Should standby subjects, the ones who are present at dosing to replace the original "panel" subjects in case they are dropped/withdrew prior to dosing in period 1, be included in the enrolled subject demographic table? Note that these standby subjects will not be dosed (and leave the clinic) if all original subjects get dosed in period 1.

A few CROs said the standbys should be included in the "enrolled subject demographic table"

Thanks
John