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Monitoring and Quality Assurance

WELCOME TO CRSO MONITORING & QUALITY ASSURANCE

The mission of the CRSO Monitoring and Quality Assurance group is to provide exceptional quality assurance and quality improvement support to Principal Investigators that are also acting as the Sponsor (i.e., Sponsor-Investigator) for drug and device clinical trials at the University of Utah and, upon request, any clinical research study across the University.

CRSO Monitoring and Quality Assurance is here to:

Provide monitoring oversight for Sponsor-Investigator IND/IDE studies

Deliver FDA audit preparation and guidance

Offer non-FDA inspection preparation and guidance

Assist with quality development activities, education, and Q/A support

Services

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