Pamela Shoup, CCRP
Past Executive Director, Toledo Community Oncology Program
Current Research Manager and IRB Coordinator for the Toledo Clinic, Inc.
Abstract: A well-organized institutional review board (IRB) ensures excellent quality assurance in the regulatory area and enables the IRB to score an A+ on regulatory inspections conducted by the U.S. Food and Drug Administration (FDA). This article describes best practices in IRB management and tools to help prepare for an FDA audit. Lessons learned from experiences at the Toledo Community Oncology Program are highlighted.
Continue reading Steps to Ensure an A+ on Your IRB Audit (Part 1) →