Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
권호 표지

Quality Management System of Clinical Research

임상시험의 품질관리체계 (Quality Management System)

  • La, Hyen-Oh (Department of Pharmacology, College of Medicine, The Catholic University of Korea, Clinical Research Coordinating Center, Catholic Medical Center)
  • 나현오 (가톨릭의대 약리학교실, 가톨릭중앙의료원 임상연구지원센터)
  • Published : 2006.06.30

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Abstract

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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