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

posted by wienui  – Germany/Oman, 2020-01-05 19:22 (1544 d 03:30 ago) – Posting: # 21057
Views: 5,350

(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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
89 visitors (0 registered, 89 guests [including 4 identified bots]).
Forum time: 22:52 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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