C1-4: Preparing for FDA Bioresearch Monitoring (BIMO) and Good Clinical Research Practice (GCP) Inspections: Fundamentals for KP Clinical Trial Sites

Abstract

Background/Aims With over 300 FDA-regulated clinical trials currently open at Kaiser Permanente Northern California (KPNC), the need for a quality-based systems approach for managing clinical trials and preparing for FDA audit of these trials is paramount. Over the past five years, the FDA’s Division of Bioresearch Monitoring (BIMO) has conducted, on average, 325 to 350 inspections of medical device clinical trials each year. In 2011, FDA issued warning letters to Sponsors, IRBs, and Clinical Investigators, citing numerous GCP violations involving pharmaceutical trials. Non-compliance findings ran the gamut; from violations related to required regulatory submissions to deviations from written procedures, and failures to maintain study documents. This presentation will: (1) discuss the triggers and types of FDA audit and the procedures necessary to prepare KP investigators and sites for a successful audit, and (2) discuss the approaches to ensure GCP and audit-readiness at all times. A case study of a routine BIMO audit of a KPNC study site participating in an investigational device trial will be presented.