Data governance in clinical trials primarily concerns which area?

• A. Management of data integrity, security, and compliance throughout the trial.
• B. Scheduling patient visits.
• C. Budget tracking.
• D. Publication ethics.

Answer: (A)

Data governance in clinical trials is about how data are created, stored, managed, and protected so their integrity and regulatory compliance are maintained from start to finish. It establishes standards for data quality, validation, data lineage, audit trails, access controls, and data security, ensuring that data are accurate, complete, and traceable. This framework supports reliable safety monitoring and statistical analysis and helps meet regulatory requirements. Scheduling visits, budgeting, and publication ethics are important areas, but they belong to trial operations, financial management, and dissemination policy rather than the governance of data itself.