SPARC performs risk-based sponsored programs and clinical research reviews to support Duke’s research enterprise. SPARC engagements evaluate process design efficiency, transactional effectiveness and internal controls against risk tolerance and operational objectives, as well as applicable federal regulations and Duke policies. Engagements support Duke’s goal of promoting and maintaining research integrity and excellence and ensuring effective sponsored program administration, oversight and reporting.
The annual SPARC compliance plan is developed through discussions with area leaders, attending various research-focused committee meetings, and staying abreast of new or revised external regulations and trends affecting research. SPARC engagements span campus, School of Medicine and School of Nursing.
- Vertical Assurance Reviews: In-depth evaluation of a unique business process or activity within a single unit
- Enterprise Assurance Reviews: Evaluation of institutionally driven processes or activity across multiple units (e.g., departments, divisions, clinical research units)
- Directed Reviews: Focused advisory or investigative reviews performed at the request of research leadership or central oversight body (e.g., Institutional Review Board (IRB))
- For-Cause Inspection Assistance: Assist study teams with federal, for-cause clinical research inspections (e.g., U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), etc.)