Pearl IRB clean FDA auditPearl IRB proudly announces the completion of a clean FDA audit. There were no significant findings during the May 2017 audit and FDA issued no 483s. Our AAHRPP accredited IRB operates in compliance with all federal and state regulations governing clinical research. These include FDA regulations 21 CFR Parts 50 and 56, DHHS regulations 45 CFR Part 46 (the Common Rule), the International Conference on Harmonization (ICH), and the Food and Drug Amendments Act of 2007 (FDAAA). Additionally, our independent review board adheres to the portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research as described in 45 CFR Parts 160 and 164.

Pearl IRB has also been audited by sponsors and contract research organizations (CROs) with no significant findings and we routinely engage in our own internal audits to ensure compliance with all relevant regulations.