A comprehensive review is given on what quality assurance means, the various methods used for quality assurance in different aspects of clinical trials and the impact of this quality assurance on outcome and every day practice. Recently there is a need of reliable data from clinical drug trials, the role and presence of quality assurance within a research site becomes more important. The use of a “Total quality management program” can be used to train and educate new clinical research coordinators and study physicians. Quality control and quality assurance are parts of quality management. Quality assurance is focused on providing confidence that quality requirements are fulfilled.
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