The Data Governance Domain of the Clinical Trial Disclosure Maturity Model
Article
Regulatory & Compliance
Article 7 in our Maturity Model series
Executive Summary
The data governance domain focuses on the integrity, data quality, and security of clinical trial disclosure information. This domain encompasses the policies, processes, and structures that govern how data is collected, validated, stored, and managed throughout the clinical trial lifecycle. Effective data governance is essential for maintaining regulatory compliance, enhancing decision-making, and building trust with stakeholders in the clinical trial disclosure process.
Why this domain matters
Data governance is necessary for reliable and compliant practices to meet regulatory disclosure requirements, maintain data privacy, and protect confidential data. It establishes the rules and standards for data management, ensuring consistency and data quality across all disclosure activities. By implementing robust data governance, organizations can enhance the accuracy of their disclosures, streamline their processes, and build confidence in their reported clinical trial information:
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About the author
Thomas Wicks
Head of Transparency Operations, Citeline
Thomas Wicks is an experienced strategic leader with over 20 years in life sciences. As Head of Transparency Operations at Citeline, he spearheads strategy for TrialScope's industry-leading disclosure solutions. Thomas is an established thought leader, having spoken at over 60 conferences and authored over 40 publications on disclosure requirements and transparency trends. Thomas is motivated by empowering teams to accelerate solutions that honor trial transparency.
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