Establishing data governance for sharing and access to real-world data: a case study

Abstract

Importance Data governance, the policies, and procedures for managing data, is a critical factor for secondary use of clinical data for research. Objectives This paper describes the evolution of an academic health-care organization's data governance for research, development of an external data sharing process, implementation of related processes, continuous improvement, and ongoing observations of data governance maturity. Materials and Methods The program was designed to improve the access to and sharing of real-world data for research. Using a combination of qualitative and quantitative methods, we evaluated the program's effectiveness. Results Our results describe a significant improvement in data accessibility as seen in new data-driven performance indicators and in data understanding indicated by new processes, policies, and strategies. Discussion The paper outlines the development of a data governance process at an academic health center to support external data sharing, emphasizing the importance of data literacy, cross-office collaboration, and structured workflows to manage complex review requirements. The formalized process improved data access, identified gaps, and enabled continuous quality improvement, though it introduced new bottlenecks and required navigating multi-office reviews and researcher education. Conclusion These findings suggest data governance practices that may apply to other institutions.