BMI in the protocol [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2022-06-29 16:44 (1082 d 11:06 ago) – Posting: # 23101
Views: 2,458

Agree with Helmut,

and I wish to point out the similarity to e.g. lab reports. When something is out of whack like SGOT a few points above the normal upper limit, the PI can always clear the subject for participation anyway, often with a relatively innocent "NCS" (or "CNS" or "OK" or "Fine" or "No problemo" etc) on source to indicate that although this is a little outside the planned range the subject is fit for trial. Same principle with the BMI and other inclusion criteria.
The decision is the investigator's.

You can be healthy without being normal, so to say.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
15 visitors (0 registered, 15 guests [including 12 identified bots]).
Forum time: 03:50 CEST (Europe/Vienna)

Law is mind without reason.    Aristotle

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