Definition of Enrolled subject [Study As­sess­ment]

posted by Ohlbe – France, 2018-07-12 00:07 (1204 d 14:34 ago) – Posting: # 19035
Views: 2,510

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:

Activity
 Admin contact
21,760 posts in 4,550 threads, 1,547 registered users;
online 11 (1 registered, 10 guests [including 7 identified bots]).
Forum time: Thursday 14:41 CEST (Europe/Vienna)

Always remember that you are absolutely unique.
Just like everyone else.    Margaret Mead

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