Establishing data governance for sharing and access to real-world data: a case study
Heath A Davis, Diva Kerkman, Asher A Hoberg, Michele Countryman, Wendy Beaver, Kiley Bybee, James M Blum, Boyd M KnospAbstract
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.