Human-Centered Clinical Data Governance: An Integrated Framework for Data Integrity, Identity Management, and Trustworthy Clinical Research
Varshika Gohar, Student, D.Pharm, Nupoor College of Pharmacy, Raipur.
Abstract
Clinical research is producing more data than ever before due to the adoption of digital tools across every stage of clinical trials. The sources of clinical data include, but are not limited to, electronic health records (EHRs), electronic case report forms (eCRFs), laboratory information systems, medical imaging systems, wearables, patient reported outcomes (PROs), clinical registries, and decentralized clinical trial technologies. This results in complex, heterogeneous clinical data environments that improve access to information but also raise important considerations related to data quality, identity, provenance, context, privacy and accountability. Clinical data governance should therefore consider these issues collectively rather than in isolation. This article introduces a human-centric clinical data governance framework that aligns multidimensional data-integrity evaluation with considerations related to identity, context, provenance, governance and human oversight. First, we review literature related to clinical data managers serving as guardians of human identity throughout clinical research. Second, we summarize our development of the Cardiac Data Integrity Score (CDIS), a tool used to objectively measure data quality across multiple dimensions. We then build on these ideas to present our human-centric clinical data governance framework. The perspective we put forth suggests that trustworthy clinical data can only be as good as the people and processes supporting it. Therefore, trustworthy clinical data should be characterized by not just being technically accurate, but complete, consistent, timely, well-governed, and fit for purpose considering its provenance, context, and identity. This framework aims to support improved reliability of data, ethical uses of artificial intelligence (AI), auditability, and human accountability throughout clinical research.
Keywords: Clinical Data Governance, Data Integrity, Clinical Trials, Human Identity, Data Quality, Data Management, Digital Identity, Data Provenance, Trustworthy Clinical Research, Artificial Intelligence
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