[ISO 9001 certification of innovation and clinical research departments: Extending the scope of health assessment]

Autor: Sambou, C., Guillemaut, S., Morelle, M., Achache, A., Le Corroller, A.-G., Perol, David, Perrier, Lionel
Přispěvatelé: Département Santé publique [Aix-Marseille Université], Aix Marseille Université (AMU), Direction de la recherche clinique et de l'innovation [Lyon] (CLCC Léon-Bérard), Centre Léon Bérard [Lyon], Groupe d'analyse et de théorie économique (GATE Lyon Saint-Étienne), École normale supérieure - Lyon (ENS Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Centre National de la Recherche Scientifique (CNRS), Direction de la qualité [Lyon] (CLCC Léon-Bérard), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U912 INSERM - Aix Marseille Univ - IRD), Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Direction de la Recherche Clinique et de l'Innovation [HCL, Lyon] (DRCI / CLCC Léon-Bérard), Centre Léon Bérard [Lyon]-Hospices Civils de Lyon (HCL), Groupe d'Analyse et de Théorie Economique Lyon - Saint-Etienne (GATE Lyon Saint-Étienne), École normale supérieure de Lyon (ENS de Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Jazyk: francouzština
Rok vydání: 2017
Předmět:
Zdroj: Epidemiology and Public Health / Revue d'Epidémiologie et de Santé Publique
Epidemiology and Public Health / Revue d'Epidémiologie et de Santé Publique, Elsevier Masson, 2017, 65 (2), pp.159-167. ⟨10.1016/j.respe.2016.12.026⟩
Epidemiology and Public Health = Revue d'Epidémiologie et de Santé Publique
Epidemiology and Public Health = Revue d'Epidémiologie et de Santé Publique, 2017, 65 (2), pp.159-167. ⟨10.1016/j.respe.2016.12.026⟩
ISSN: 0398-7620
1773-0627
Popis: International audience; BACKGROUND:The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies.METHOD:All of the processes, procedures, operating modes, documents, and indicators used by the clinical research and innovation department of the Léon-Bérard center were investigated. Literature searches were conducted using Medline keywords. The recommendations from the French national authority for health and other organizations, such as the International society for pharmacoeconomics and outcomes research (ISPOR), were also considered, as well as the recommendations of the General inspectorate of social affairs.RESULTS:In accordance with the national and international recommendations, two procedures were created and four procedures were revised at this center. Five indicators of quality and an evaluation chart were developed.CONCLUSION:By adopting the ISO 9001 certification into its medico-economic studies, the clinical research and innovation department of the Léon-Bérard center has used an innovative approach in the context of the growing importance of economic studies in decision-making.Copyright © 2017 Elsevier Masson SAS. All rights reserved.
Databáze: OpenAIRE
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