Posted by Rockleo on another board: From: R
Post# of 153887
(Total Views: 708)
Posted On: 04/04/2022 11:44:50 AM
Posted by Rockleo on another board:
Quote:
From: Rockleo
Monday, April 04, 2022 12:52:59 AM
Re: Chuckles759 post# 206781
Post# of 206801
Chuckles 759… My 2 Cents on Safety..!!!
A Clinical Trial Site has 24 hrs to report a SAE , that it becomes aware of… both to the Sponsor AND the IRB , overlooking the study.
Amarex May have been casual in it’s approach regarding Safety signals..!!!
However..!!!
The IRB’s overlooking our studies were the ones..EACH AND EVERY SAE..was reported to. These IRB’s are responsible to evaluate the causality determined by the investigator .. and determine whether the drug may continue to be administered to patients..!!!
Amarex has NOTHING to do with our Clinical Trial Investigators reporting SAE’s to the IRB..!!!
To assume ALL the investigators..ALL the IRB’s conducting CYDY sponsored studies..were incompetent..is a stretch..!!!
At the conclusion of each study..Amarex had to have EVERY Clinical Trial Site ..Close out EVERY SAE..that occurred at THEIR site.
The close out report by Amarex had to include every SAE ..reported during the study.
This report is sent to the overlooking IRB..Which independently verifies the SAE’s reported in the close out report by Amarex..With the SAE’s it independently received from the Clinical Trial Sites..!!!
The chances of rogue Physicians and IRB’s spread all across our country..Coming together just in CYDY trials..!!!
In small to NONE..!!!
IMHO.
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