David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
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Science and Engineering Ethics 12 (1):147-156 (2006)
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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Raymond E. Spier (2006). Conference Summary: 'The Responsible Conduct of Basic and Clinical Research'. Science and Engineering Ethics 12 (1):189-197.
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