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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) →