BMI limits [Design Issues]

posted by ElMaestro  – Belgium?, 2018-10-31 09:19 (695 d 18:44 ago) – Posting: # 19505
Views: 2,679

Hi Amira Gouda,

» I agree with you, we should strictly follow the study protocol, (NB: protocol BMI range : 18.5 -30 ), but if principal investigator approved this deviation (31.5), recorded in protocol deviation log and submitted to IRB/IEC, what do you think?

On basis of my modest experience situations like this tend to arise out of bad planning when the CRO is running out of eligible subjects close the projected start of the study. That's the time when they start approving all sorts of deviations on BMI, blood sugar, ALAT/ASAT, HB/hematocrit and more in order to be able to meet the enrollment target and stay on time.
You do not ever want to be confronted with questions going in that direction.

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

I could be wrong, but...

Best regards,

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

Complete thread:

 Admin contact
21,076 posts in 4,394 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Saturday 05:04 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

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