BMI limits [Design Issues]

posted by Amira Gouda – Egypt, 2018-10-31 14:59 (1975 d 01:45 ago) – Posting: # 19509
Views: 3,493

❝ What did the PI submit to the IEC/IRB and when exactly?


Hi,

In such cases PI will submit to IEC/IRB before enrollment of the subject to BE study that he have for example one subject with deviation in BMI which is non significant to the trial and needed to complete sample size

Thanks,


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
64 visitors (1 registered, 63 guests [including 3 identified bots]).
Forum time: 16:44 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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