The Data Governance Domain of the Citeline Maturity Model for Clinical Trial Disclosure
Article
薬事規制関連支援サービス
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:
Read more
Take the Maturity Model Self-Assessment
This interactive tool will guide you through a comprehensive evaluation of your organization's disclosure practices, enabling you to identify strengths, pinpoint areas for improvement, and chart a clear path toward greater transparency and compliance.
About the author
Thomas Wicks
Head of Transparency Operations, Citeline
ライフサイエンス分野で20年以上の経験を持つ戦略リーダーであり、現在はCitelineの透明性業務責任者を務めています。業界をリードするTrialScopeの情報開示ソリューションの戦略を指揮し、透明性に関する深い知識と実績を持っています。
トーマスは、情報開示要件や透明性のトレンドについてのオピニオンリーダーとしても高く評価されており、これまでに60以上のカンファレンスで講演し、40以上の出版物を執筆しています。また、裁判の透明性を尊重するソリューションを加速させることを使命とし、チームに力を与えることに情熱を注いでいます。
