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

TL;DR

This paper outlines how an academic health center improved data governance to better share real-world clinical data for research.

Contribution

The paper presents a case study on evolving data governance practices to enhance data accessibility and sharing for research.

Findings

A formalized data governance process significantly improved data accessibility and understanding.

The program identified gaps and enabled continuous quality improvement in data sharing.

New bottlenecks emerged, requiring multi-office reviews and researcher education.

Abstract

Data governance, the policies, and procedures for managing data, is a critical factor for secondary use of clinical data for research.

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.

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.

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.

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.

These findings suggest data governance practices that may apply to other institutions.

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