Definition of Enrolled subject [Study As­sess­ment]

posted by Ohlbe – France, 2018-07-12 00:07 (1114 d 23:16 ago) – Posting: # 19035
Views: 2,413

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
21,594 posts in 4,515 threads, 1,532 registered users;
online 18 (0 registered, 18 guests [including 5 identified bots]).
Forum time: Friday 23:23 CEST (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

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