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Monitoring and Quality Assurance

Montoring and Quality Assurance

The Clinical Research Support Office Quality Assurance (CRSO QA) Group protects Sponsor-Investigators at the University of Utah by monitoring all Sponsor-Investigator trials where the Investigator holds an IND/IDE application with the FDA, regardless of concurrent departmental/contracted monitoring services. The CRSO QA Group may also monitor Nationally-funded (or Network) interventional trials that are without monitoring support. The purpose of the CROS QA activities are to ensure that clinical trials adhere to research protocols, applicable Federal and State regulations, ICH GCP guidelines, and all University policies and procedures. 

All Sponsor-Investigator studies are monitored for the following

  • Protocol compliance and deviations
  • Informed consent
  • Adherence to GCP
  • Adherence to regulations, guidelines, and SOPs
  • IRB applications, approval notices, reports, correspondence
  • Conflict of interest/financial disclosure
  • Safety reporting
  • Pharmacy and investigational product (IP) accountability
  • Laboratory procedures
  • Training records
  • Site support
  • Adverse events (AE)/safety review
  • Essential document review
  • Source data verification (SDV)
  • Site performance assessment
  • Study progress against milestones

 

In addition, the CRSO QA team provides the following services, as needed:

  • Review Investigator-Initiated Trials (IIT) protocols prior to study start-up
  • Provide mentorship and training for study teams
  • Conduct pre-reviews prior to FDA and audits by other entities
  • Develop Standard Operating Procedures and guidance documents

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