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 was inspected by the FDA in 1999, 2005 and again in 2010 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 and 2011. In May 2010, CGIRB was awarded ISO 9001:2008 certification. CGIRB is registered with the Office for Human Research Protections (OHRP and FDA) as IRB00001313, enabling the review of HHS-supported or -conducted human subjects research under the Federalwide Assurance (FWA) of a submitting body. CGIRB's primary responsibility is to ensure that the rights and welfare of human research subjects are protected. The CGIRB Board reviews research protocols and study-related information, as well as investigator qualifications and resources to assure regulatory compliance. Copernicus Group IRB may review studies for a single investigator or serve as a central IRB for multi-center trials involving upwards of several thousand investigators. Additionally, CGIRB may function as the IRB of record for studies conducted at hospitals or academic institutions.