BMI limits [Design Issues]

posted by Amira Gouda – Egypt, 2018-10-31 14:59 (2057 d 21:49 ago) – Posting: # 19509
Views: 3,731

❝ 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
23,058 posts in 4,840 threads, 1,641 registered users;
130 visitors (0 registered, 130 guests [including 8 identified bots]).
Forum time: 13:49 CEST (Europe/Vienna)

Even though it’s applied science we’re
dealin’ with, it still is – science!    Leslie Z. Benet

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