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Case Reports
. 2025 Jun 23;8(3):ooaf041.
doi: 10.1093/jamiaopen/ooaf041. eCollection 2025 Jun.

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

Heath A Davis  1   2 , Diva Kerkman  2 , Asher A Hoberg  1   2 , Michele Countryman  3 , Wendy Beaver  4 , Kiley Bybee  5 , James M Blum  6   7 , Boyd M Knosp  1   2
Affiliations
Case Reports

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

Heath A Davis et al. JAMIA Open. .

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.

Keywords: Enterprise Data Warehouse for Research; clinical research data; data governance; external data sharing for research; real-world data; research data.

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Conflict of interest statement

The authors have no competing interests.

Figures

Figure 1.
Figure 1.
At stops 1-5, the outcomes can be (1) request for information or clarification from the researcher, (2) reviewed and send to the next stop without concerns, or (3) reviewed and send to the next stop with concerns documented. At stop 6, the request is approved with the Data Use Agreement Approved internal sharing with the Internal Data Use Agreement, redirected to existing resources within health care.
Figure 2.
Figure 2.
The process includes determining if: (1) the request contains health-care data, (2) data are leaving health care, (3) data are leaving the university, and (4) subjects are consented for data sharing.
Figure 3.
Figure 3.
Time to recommendation by the Working Group and Task Force.
See this image and copyright information in PMC

References

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