FDA EIR - Amita Health IRB - August 23, 2018

A U.S. Food and Drug Administration (FDA) inspection of Amita Health IRB, located in Elk Grove Village, IL, was conducted from August 21 to August 23, 2018. This initial inspection of Amita Health IRB, performed by the Center for Drug Evaluation and Research (CDER) Office of Scientific Investigations, followed Compliance Program 7348.809, focusing on Institutional Review Board operations. The review covered major program elements including IRB membership, meetings, written procedures for project review and approval, adverse event reporting, and informed consent, adhering to federal regulations such as 21 CFR Part 56 and 21 CFR Part 50. Although no Form FDA 483 (Inspectional Observations) was issued, several discrepancies and practices were discussed with IRB management. These included inconsistencies in IRB membership qualifications between rosters and meeting minutes, a lack of detailed new member training specifics in standard operating procedures, and missing original membership applications for co-chairpersons. Additionally, some meeting minutes lacked identification of the central IRB used or the date of prior minutes reviewed. The practice of allowing personnel to copy and paste signatures onto documents was also noted. Furthermore, a clinical investigator failed to provide a follow-up report for a compassionate use study. Amita Health IRB management indicated that corrective actions would be implemented for all discussed observations. This includes enhancing accuracy in recording membership details, updating training procedures for new members, ensuring proper document filing, improving consistency in meeting minute content, and considering a future requirement for 'wet' signatures on original documents.