Definition of Enrolled subject [Study As­sess­ment]

posted by Ohlbe – France, 2018-07-12 02:07 (2087 d 13:48 ago) – Posting: # 19035
Views: 2,975

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.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
110 visitors (0 registered, 110 guests [including 8 identified bots]).
Forum time: 14:55 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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