The concept of quality in clinical research

Science and Engineering Ethics 12 (1):147-156 (2006)

Abstract
Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000.
Keywords Quality  Quality Management System (QMS)  clinical research process  clinical research customers  Quality Control (QC)  Quality Assurance (QA)  GXP
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DOI 10.1007/s11948-006-0015-x
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