Definition of Enrolled subject [Study As­sess­ment]

posted by Ohlbe – France, 2018-07-12 00:07 (873 d 08:13 ago) – Posting: # 19035
Views: 2,200

Hi John,

» 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.


Complete thread:

 Admin contact
21,224 posts in 4,427 threads, 1,481 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Tuesday 07:20 CET (Europe/Vienna)

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt.    Bertrand Russell

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