Data Governance Policies

Integrating Governance into Risk-Based Monitoring

Posted on digi By digi

The traditional model of 100% source data verification at every clinical site is no longer sustainable for modern trials. Sponsors and CROs now employ risk-based monitoring (RBM) strategies to focus resources on the most critical data, processes, and sites. However, as monitoring becomes more selective, the role of governance becomes even more vital.

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Data Governance Policies, Data Integrity and ALCOA+ Principles

SOPs for Implementing Data Governance at Sponsor Organizations

Posted on digi By digi

In the clinical research industry, the effectiveness of data governance is only as strong as the SOPs that support it. For sponsor organizations, having robust, documented, and enforceable standard operating procedures (SOPs) is the only way to ensure consistent, ALCOA+ compliant data management across studies, systems, and sites.

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Data Governance Policies, Data Integrity and ALCOA+ Principles