Semantic Modelling of Organizational Knowledge as a Basis for Enterprise Data Governance 4.0 -- Application to a Unified Clinical Data Model

Abstract: Individuals and organizations cope with an always-growing amount of data, which is heterogeneous in its contents and formats. An adequate data management process yielding data quality and control over its lifecycle is a prerequisite to getting value out of this data and minimizing inherent risks related to multiple usages. Common data governance frameworks rely on people, policies, and processes that fall short of the overwhelming complexity of data. Yet, harnessing this complexity is necessary to achieve high-quality standards. The latter will condition any downstream data usage outcome, including generative artificial intelligence trained on this data. In this paper, we report our concrete experience establishing a simple, cost-efficient framework that enables metadata-driven, agile and (semi-)automated data governance (i.e. Data Governance 4.0). We explain how we implement and use this framework to integrate 25 years of clinical study data at an enterprise scale in a fully productive environment. The framework encompasses both methodologies and technologies leveraging semantic web principles. We built a knowledge graph describing avatars of data assets in their business context, including governance principles. Multiple ontologies articulated by an enterprise upper ontology enable key governance actions such as FAIRification, lifecycle management, definition of roles and responsibilities, lineage across transformations and provenance from source systems. This metadata model is the keystone to data governance 4.0: a semi-automatised data management process that considers the business context in an agile manner to adapt governance constraints to each use case and dynamically tune it based on business changes.