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Towards Reliable Clinical Data: A Collaborative Data Governance Architecture with Lifecycle Integration.

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A new Comprehensive Clinical Data Governance Architecture (CCDGA) improved clinical data quality by embedding proactive controls into workflows. This approach enhanced data completeness and standardization, moving beyond retrospective fixes for reliable healthcare decision-making.

Keywords:
Clinical data qualityCollaborative interventionData governanceData lifecycle managementInterrupted time series

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Area of Science:

  • Health Informatics
  • Clinical Data Management
  • Healthcare Quality Improvement

Background:

  • Clinical data accuracy and completeness are vital for healthcare decision-making and research.
  • Existing data quality frameworks often rely on post-hoc corrections and are not integrated into clinical workflows.
  • This limits the real-world reliability of clinical data.

Purpose of the Study:

  • To develop and evaluate a proactive, workflow-embedded, lifecycle-oriented governance architecture for clinical data.
  • To address limitations in current data quality frameworks by integrating governance upstream in the data capture process.

Main Methods:

  • The Comprehensive Clinical Data Governance Architecture (CCDGA) was proposed, integrating a Data Lifecycle Framework (DLF) and a Collaborative Data Governance Framework (CDGF).
  • A Data Governance Committee provided organizational oversight, creating a closed-loop system embedded in data capture.
  • A postpartum hemorrhage (PPH) case study in a tertiary maternal hospital utilized interrupted time series (ITS) analysis.

Main Results:

  • Significant improvements were observed in data completeness (β₂ = 30.849, P < 0.001) and standardized data entry (β₂ = 80.163, P < 0.001).
  • A positive trend in standardized data entry was noted post-intervention (β₃ = 0.193, P = 0.045).
  • Alignable record rates also improved significantly (β₂ = 29.812, P < 0.001).

Conclusions:

  • The CCDGA offers a lifecycle-informed governance model integrating collaborative interventions and oversight.
  • Embedding governance upstream shifts assurance from retrospective auditing to proactive, process-integrated improvement.
  • The PPH case study demonstrated stabilized completeness and improved standardization, supporting scalable clinical data governance.