Definition of Enrolled subject [Study As­sess­ment]

posted by jag009  – NJ, 2018-07-11 21:27 (1490 d 00:52 ago) – Posting: # 19034
Views: 3,142

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:

UA Flag
Activity
 Admin contact
22,289 posts in 4,666 threads, 1,585 registered users;
online 6 (0 registered, 6 guests [including 2 identified bots]).
Forum time: Tuesday 22:19 CEST (Europe/Vienna)

The existing scientific concepts cover always only
a very limited part of reality,
and the other part that has not yet
been understood is infinite.    Werner Heisenberg

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