EDC system roles – Clinical Research Made Simple

Configuring EDC Systems for ALCOA+ Compliance

August 28, 2025

Configuring EDC Systems for ALCOA+ Compliance How to Configure EDC Audit Trails for ALCOA+ and Regulatory Compliance Understanding ALCOA+ and Its Implications for Audit Trails The ALCOA+ framework—Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available—defines the cornerstone of data integrity in clinical trials. For EDC (Electronic Data Capture) systems, achieving ALCOA+ compliance…

Audit Trail Reviews in EDC, Audit Trails and Inspection Readiness

Roles and Responsibilities in Clinical Data Governance

August 2, 2025

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Roles and Responsibilities in Clinical Data Governance Defining Roles and Responsibilities in Clinical Data Governance Why Role Clarity Is Foundational to Data Integrity Data governance is only effective when all stakeholders understand their responsibilities. In clinical research, unclear ownership and poorly defined roles can lead to inconsistent data, audit trail gaps, and even critical inspection…

Data Governance Policies, Data Integrity and ALCOA+ Principles