Posting: # 19034
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"
Posting: # 19035
» A few CROs said the standbys should be included in the "enrolled subject demographic table"
IMHO they should be listed on the inclusion log in the TMF, but I don't see the point in adding their data to the demographics table. They were not dosed and their data are not used in any way to assess BE.