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):
Pre-IRB IND/IDE Audit
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Conducted prior to IRB approval of the New Study Application
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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
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First monitoring visit initiated after the first participant has been enrolled to the study
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Routine risk-based monitoring visits conducted through study close out
Services For All investigators:
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FDA Audit Support
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Non-FDA Audit Support