- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
What Does QI Do?
Research QI Reviews:
- Regulatory and Good Clinical Practice (GCP) Reviews
- Compliance with UR policy/procedures, UR Conflict of Interest process
- Assist sites to be "audit-ready"
- Site education during review process
- Conducted upon request after IRB approval and before subject enrollment
- Provide on-site education to research team members regarding applicable regulations and policies required to ensure human subject protection, protocol compliance, and overall research documentation.
Quality Management Plan Consultations:
- Conducted upon request
- Provide on-site brainstorming and education to research team members regarding quality improvement opportunities to ensure human subject protection, protocol compliance, and overall research documentation.
Resource for Research Community:
- Consent issues, Unanticipated Events, Adverse Events, and other concerns
- Site/Study specific education and training