Clinical Research Accountability Units
SOM Clinical Research Accountability Units (CRAUs)
The UNC School of Medicine (SOM) human subjects research portfolio is managed by many highly capable and proficient teams, units, programs, initiatives, centers, and departments across the School. While this organization of personnel, effort, and activities allows each unit to focus on their unique priorities and functions, the somewhat siloed nature of the organization creates challenges related to communication, accountability, efficiency, and collaboration. To enable vital communication, bolster accountability, and promote efficiency through standardization, the SOM is establishing Clinical Research Accountability Units (CRAUs).
CRAUs have three primary functions to meet these overarching goals:
- Communication: Establishing a primary point of contact for every CRAU so that information and resources are appropriately disseminated from the SOM, its Clinical Research Support Office (CRSO), and the Offices of the Vice Chancellor of Research (OVCR) to research teams; which enables the CRSO to better understand priorities and challenges faced by research teams.
- Accountability: Developing methods to verify the accuracy of administrative data to appropriately understand and account for all studies and personnel involved in human subjects research.
- Standardization: Disseminating and promoting established best practices and standard operating procedures to promote efficiency.
There are many other anticipated benefits of establishing CRAUs:
- Enhance research compliance
- Improve overall quality, conduct, and financial performance of research studies
- Reduce burden for university research offices
- Increase negotiating power with sponsors
- Improve research faculty recruitment
- Create greater opportunities for progressive responsibility and career growth for clinical research staff
- Foster unity and peer support among research staff
- Minimize limitations and inequities caused by research team silos
Establishing the CRAUs
CRAUs are standardized infrastructure accountable for the human subjects research portfolio of the SOM that are based primarily in SOM clinical departments. CRAUs will have many common elements, but detailed structure and division of responsibilities will vary based on existing infrastructure and unique opportunities specific to each department.
The process of establishing a new CRAU involves collaborative discussion between CRSO personnel and designated departmental research personnel to recognize existing workflows, understand the landscape of research studies and activities, and consider priorities and opportunities. Through this collaborative discovery, a charter document is developed to document specific responsibilities and processes. Once the CRAU charter is finalized, the CRSO and CRAU personnel will initiate routine communications to support the goals and mission of the CRAUs and CRSO.
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