BMI limits [Design Issues]

posted by ElMaestro  – Belgium?, 2018-10-31 09:19 (757 d 14:58 ago) – Posting: # 19505
Views: 2,709

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,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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