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Internal Compliance Assessment Process

The College of Medicine Office of Research has a clinical trial compliance assessment process that focuses on the fundamentals of conducting clinical research studies at The Ohio State University. The review includes the assessment of subject safety, protocol compliance and compliance with Good Clinical Practices, applicable federal regulations and institutional policies.

COMOR Compliance Assessment Manual_FEB2019.pdfCOMOR Compliance Assessment Manual_FEB2019.pdf

A self-audit checklist has been developed to assist our researchers with the COMOR Compliance Assessments by making expectations as transparent as possible. If during the course of the self-assessment protocol deviations or violations are found, please look to the IRB and sponsor reporting requirements.