Accès gratuit
Numéro
Therapie
Volume 65, Numéro 4, Juillet-Août 2010
Page(s) 291 - 299
Section Affaires réglementaires / Regulatory System
DOI https://doi.org/10.2515/therapie/2010037
Publié en ligne 21 septembre 2010
  1. Pehboeck D, Hohlrieder M, Wenzel V, Submission of clinical studies to Ethics Committees or clinical trials registers – the authors’ point of view. Intensive Care Med 2009; 35: 713-6 [CrossRef] [PubMed] [Google Scholar]
  2. European Forum for Good Clinical Practice (EFGCP).Conference on the Impact on Clinical Research of European Legislation (FP7 program, ICREL), results § discussion, Brussels 2 Dec 2008. http://www.efgcp.be/Downloads/confDocuments/Programme_ICREL_2_Dec_2008_final.pdf [Google Scholar]
  3. Kubiak C, De Andres-Trelles F, Kuchinke W, Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). Trials 2009; 10: 95-101 [CrossRef] [PubMed] [Google Scholar]
  4. Jardé O. Projet de Loi sur les recherches sur la personne. Assemblée Nationale, 22 janvier 2009. http://www.assembleenationale.fr [Google Scholar]
  5. Clinical Trials Facilitation Group: CTA assessment in member states, 22 December 2008. http://www.hma.eu/uploads/media/Assessment_in_MS_public_dec_08__2_B.pdf. [Google Scholar]
  6. European Network of Research Ethics Committees (EUREC). http://www.eurecnet.org/index.html [Google Scholar]
  7. Bertoye PH, Courcier-Duplantier S, Best N. Adaptation de la mise en oeuvre des bonnes pratiques cliniques en fonction des caractéristiques de certaines recherches. Thérapie 2006; 61: 271-7 [CrossRef] [EDP Sciences] [Google Scholar]
  8. Projet Optimon, OPTimisation du MONitorage : évaluation de l’efficacité et du coût de deux stratégies de monitorage pour la recherche clinique institutionnelle. Version du 4 février 2008. https://ssl2.isped.ubordeaux2.fr/optimon/Documents.aspx [Google Scholar]
  9. Notes on good practice for research organisations in the management of a portfolio of trials 2: assessment of risk. Clinical trials tool kit issued by the Department of Health and the Medical Research Council (MRC), 2004. http://www.cttoolkit.ac.uk/_db/_documents/MPTrials2.pdf [Google Scholar]
  10. Wolzt M, Druml C, Leitner D, et al. Protocols in expedited review–tackling the workload of Ethics Committees. Intensive Care Med 2009; 35: 613-5 [CrossRef] [PubMed] [Google Scholar]
  11. Brosteanu O, Houben P, Ihrig K, Risk analysis and risk adapted on-site monitoring in non commercial clinical trials. Clin Trials 2009; 6: 585-96 [CrossRef] [PubMed] [Google Scholar]
  12. European Commission. Assessment of the functioning of the Clinical Trials Directive 2001/20/EC: public consultation paper ENTR/F/2/SF D (2009) 32674. 09/10/2009. http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/clinicaltrials/docs/2009_10_09_publicconsultationpaper.pdf [Google Scholar]