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Re: asuato post# 21335

Monday, 12/21/2009 8:50:42 AM

Monday, December 21, 2009 8:50:42 AM

Post# of 92949
asuato,

If the IND is approved it will not appear on that site until, at the very minimum, the IRB is complete.



"A trial must be approved by a human subject review board and must conform to the regulations of the appropriate national health authorities, in order to be registered."
http://www.clinicaltrials.gov/ct2/invest

from CEO Caldwell
"As soon as we receive clearance from the FDA, we will finalize our investigators and sponsoring eye clinic or hospital and begin a process to gain IRB (Institutional Review Board) approval to conduct the trials at that particular site. Typically, that process takes 60-90 days depending on the institution’s internal protocol approval requirements.

What is the IRB?
The Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects.
The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
http://www.ohre.unc.edu/guide_to_irb.php#whatirb

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