Replacing a subject withdrawn for dose failure with a stand-by subject [Study Per­for­mance]

posted by VSP – India, 2017-05-07 21:10 (1191 d 02:38 ago) – Posting: # 17313
Views: 3,822

Hi All,

I would like to request you all kindly clarify, whether replacing a subject withdrawn for dose failure (ex., Sub-lingual Film) with a stand-by subject will be considered contradiction/violation of protocol?

Thanks in advance
VSP

Complete thread:

Activity
 Admin contact
20,996 posts in 4,377 threads, 1,460 registered users;
online 24 (0 registered, 24 guests [including 12 identified bots]).
Forum time: Monday 23:48 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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