Monitoring & Quality Assurance

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Welcome To

The CRSO Quality Assurance Team

CRSO QA

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.

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CRSO Monitoring Oversight:

CRSO QA provides the following monitoring services to University of Utah investigators:

Investigator-Initiated Trials (IITs) that hold an Investigational New Drug (IND)/ Investigational Device Exemption (IDE):

  • First monitoring visit initiated after the first participant has been enrolled to the study
  • Routine risk-based monitoring visits conducted through study close out. 
  • Pre-IRB IND/IDE Audit:
    • Conducted prior to IRB approval of the New Study Application
    • Ensures that all required documentation is in place before the study begins, increasing the study team's ability to maintain compliance   with FDA regulation: Click for additional information
  • For more information on how monitoring visits are conducted, reference the CRSO QA Monitoring SOP

All investigators:

 

Monitoring Oversight

FDA Audit Support

Non-FDA Audit Support

Additional Quality Assurance and Improvement Services

Contact Us

Email: CRSOQA@hsc.utah.edu