title: The concept of quality in clinical research.
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.
authors.affiliation: AstraZeneca Global Clinical Quality Assurance, Poland. Dorota.Switula@astrazeneca.com
authors.forename: Dorota
authors.initials: D
authors.lastname: Switula
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D017749:Total Quality Management