FDA EIR - Copernicus Group IRB #1 - March 12, 2018

An FDA inspection of Copernicus Group IRB #1 in Cary, NC, was conducted from March 8 to March 12, 2018. The inspection aimed to assess the institutional review board's compliance with current regulations, specifically 21 CFR Parts 50 (Protection of Human Subjects) and 56 (Institutional Review Boards), under Compliance Program 7348.809. The assessment covered three FDA-regulated drug studies to evaluate the IRB's procedures and adherence to applicable regulations. Inspectors reviewed the IRB's standard operating procedures, membership roster, committee meeting minutes, and its registration with the Office of Human Research Protections (OHRP). The review found that the board's composition complied with 21 CFR 56.107, and its written procedures for initial study approval, continuing review, expedited review, and informed consent were adequate. Meeting minutes consistently documented discussions, deliberations, votes, and recusal of members with conflicts of interest. Crucially, the inspection concluded that Copernicus Group IRB #1 appeared to be operating in general compliance with FDA regulations. As a result, no Form FDA 483, Inspectional Observations, was issued, and no objectionable conditions were noted. Therefore, no specific regulatory actions were required from the company following this inspection.