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.