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Darlene Jutting Email
Senior Site Submission Specialist . Copernicus Group IRB
Durham, NC
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Copernicus Group IRB (CGIRB) was established in July 1996 as an independent institutional review board (IRB or “Board”) and is organized and operates in compliance with regulations governing institutional review boards set forth in 21 CFR and ICH guidelines, as well as 45 CFR when applicable. CGIRB is a member of the Consortium of Independent Review Boards (CIRB), a group of independent IRBs that regularly meets to review issues of importance to the protection of human research subjects. CGIRB was inspected by the FDA in 1999 and again in 2005 with no Form FDA 483 issued. In 2004, CGIRB was awarded full accreditation of the human research protection program by AAHRPP®, The Association for the Accreditation of Human Research Protection Programs, Inc, and was awarded full reaccreditation in 2007. CGIRB is registered with the Office for Human Research Protections (OHRP) as IRB00001313, enabling the review of HHS-supported or -conducted human subjects research under the Federalwide Assurance (FWA) of a submitting body.Copernicus Group IRB Address
One Triangle DriveDurham, NC
United States