The same PI for two studies in the same time [Study As­sess­ment]

posted by wienui  – Germany, Oman, 2020-01-05 18:22 (294 d 13:25 ago) – Posting: # 21057
Views: 3,403

(edited by wienui on 2020-01-05 19:44)

Dear colleagues,

First of all, I wish you a happy successful new 2020.

I face a situation for the first time, during evaluation of a BE study for a formulation which should be performed in fasting and fed conditions. both studies conducted in the same starting and ending period dates, till the moment I don't have something against that, but what makes me very worry is that both study were conducted in the same clinical site and both have the same principle investigator !!!

Is there any GCP Guidelines which regulate ( allowed or prohibited) this issue?

Best regards,
Osama

Cheers,
Osama

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