Definition of Enrolled subject [Study As­sess­ment]

posted by jag009  – NJ, 2018-07-11 21:27 (1204 d 16:07 ago) – Posting: # 19034
Views: 2,979

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

Complete thread:

Activity
 Admin contact
21,760 posts in 4,550 threads, 1,546 registered users;
online 20 (0 registered, 20 guests [including 9 identified bots]).
Forum time: Thursday 13:34 CEST (Europe/Vienna)

Always remember that you are absolutely unique.
Just like everyone else.    Margaret Mead

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5