Journal of Clinical Trials and Regulatory Affairs

Building Quality Assurance (QA) and Risk-Based Quality Management (RBQM) Systems into Clinical Research Operations. An Academic Site Perspective

Author(s): Marina A Malikova

Organizations conducting clinical research can benefit from establishing quality and risk management systems to measure performance, using objective metrics to measure efficiency, safety and quality. The development of metrics involves identifying the values of an organization and the goals that express those values, developing measures to assess meeting those goals, and building infrastructure to capture data to support the metrics and develop adequate and timely response to drive improvement.

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