The Clinical Research Support Center conducts quality assurance (QA) reviews for investigator-initiated human subjects research studies at the University of Colorado Denver and Anschutz Medical Campuses and some affiliate institutions that are sponsored by University faculty members. QA Reviews are conducted on a routine basis for sponsor investigator-led trials, and on a random basis for all other studies. In addition, study teams may request a visit from the QA team. 

Study teams conducting investigator-initiated research usually don’t have access to the robust monitoring services of an external industry sponsor or CRO. We are here to help fill that gap.

What happens during the review process?

Quality assurance reviews are informative and educational, based on federal regulations, institutional policies and procedures and local laws. Your team will be provided with practical guidance and tools for conducting your research. 

If your study is selected, or you have requested a review, we will contact you to set up an appointment.

  • At the visit, we will meet with you, review your study records and help you identify any inconsistencies or errors:
    • Study documentation, including your regulatory binder, subject binders, investigational product records and CTMS records
    • Regulatory and IRB submissions and status, including ClinicalTrials.gov record status
    • Training records for the study team
    • Your internal SOPs, forms, and tools used to manage your study
  • After the visit, we will meet with you and provide you with a detailed report. This report does not constitute any punitive action. Instead, it’s a road map to guide you toward opportunities to improve your study compliance and align yourself with best practices.
We are happy to answer any questions you may have during the process. 

Additional Resources