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KMID : 0391020060140010023
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2006 Volume.14 No. 1 p.23 ~ p.28
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Quality Management System
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La Hyen-O
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Abstract
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A quality is a set of characteristics that a product and service have to satisfy requirements of the customers; research subjects, sponsors, regulatory authorities worldwide, hospitals and IRB/IECs. In Clinical Research products are information from the clinical research process and requirements are law & regulations, GCP, ethical standards, trial protocol, budget and timeline. Quality Control(QC) of Clinical Research is activity that checks on the compliance of the trial process & reliability and credibility of data. QC is performed at every step of the clinical trial process and applied to each stage of data handling. Quality Assurance (QA) of Clinical Research is independent audits of all trial-related processes & functions. QA is performed by QA team not involved in the research process and assess efficiency of sponsors’ QC processes. Quality Management System(QMS) is a set of tools to ensure, control, maintain, and improve quality. QMS supports continuous Quality Improvement(QI). QI is peformed by FOCUS-PDLA cycle.
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KEYWORD
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Quality control, Quality assurance, Quality management system, Quality improvement
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