Definition of Enrolled subject [Study As­sess­ment]

posted by jag009  – NJ, 2018-07-17 06:36 (963 d 10:42 ago) – Posting: # 19075
Views: 2,197

Thanks Ohlbe

» 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.

That's my thinking as well. I asked the CRO and their reply was "That's how our clinic has been doing it" :no:

John

Complete thread:

Activity
 Admin contact
21,371 posts in 4,463 threads, 1,495 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time: Saturday 16:19 CET (Europe/Vienna)

If debugging is the process of removing bugs,
then programming must be the process of putting them in.    Edsger W. Dijkstra

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