BMI limits [Design Issues]

posted by Amira Gouda – Egypt, 2018-10-31 13:59 (1174 d 04:08 ago) – Posting: # 19509
Views: 2,988

» 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]

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