BMI limits [Design Issues]

posted by Ohlbe – France, 2018-10-30 23:48 (1134 d 18:05 ago) – Posting: # 19503
Views: 2,993

Dear Amira,

» if principal investigator approved this deviation (31.5), recorded in protocol deviation log and submitted to IRB/IEC, what do you think?

That it is still a protocol deviation, and non-compliance with ICH GCP sections 4.5.1 and 4.5.2. Unlikely to cause the rejection of the trial, but if there are too many of these, it may trigger questions and possibly an inspection.

Regards
Ohlbe

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