Steps to Ensure an A+ on Your IRB Audit (Part 2)

medical practitioners having a meeting in a hospital boardroom

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IRB Audits and Inspections

IRB audits can be conducted by federal agencies overseeing research such as the FDA or the Office for Human Research Protections, research bases, study sponsors, and IRBs. Pharmaceutical sponsors do routine monitoring of their studies at regular intervals. The Toledo Community Oncology Program’s research bases only audited the program every three years. This can make it difficult to know about mistakes made years earlier and to put quality assurance processes in place when needed.

Continue reading Steps to Ensure an A+ on Your IRB Audit (Part 2)

Steps to Ensure an A+ on Your IRB Audit (Part 1)

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)