Definition of Enrolled subject [Study As­sess­ment]

posted by jag009  – NJ, 2018-07-11 21:27 (928 d 02:50 ago) – Posting: # 19034
Views: 2,632

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
21,310 posts in 4,445 threads, 1,489 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Sunday 23:18 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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