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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):


  • 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 

  • First monitoring visit initiated after the first participant has been enrolled to the study

  • Routine risk-based monitoring visits conducted through study close out

Services For All investigators: