Clinical Research Units (CRU) provide the organizing structure for the conduct of any research in the School of Medicine (SOM) in which a Duke Faculty member is responsible for the involvement of human subjects. The CRU is the operating and business unit responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of this research activity.
All research projects involving human subjects should be conducted within the Radiology CRU.
WHAT ARE THE SCIENTIFIC GOALS OF THE CRU?
- To provide clinical/translational research that is innovative and cutting edge.
- To create standardized clinical research processes that are cost-effective and time sensitive.
- To regulate research methods to help ensure valid findings.
- To provide a standard of practice that ensures transparency to the sponsor and subjects.
- To provide education and mentorship for faculty and staff.
WHAT ARE THE FUNCTIONS OF THE CRU?
- To review research projects.
- To prepare research budgets.
- To coordinate contract negotiations.
- To assist in the preparation and submission of research projects
- To identify, screen, enroll, and obtain consent from potential subjects.
- To collect data and maintain study records.
- To perform study audits/monitoring visits.
- To track and validate billing milestones and invoice timely and accordingly.