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Volumn 65, Issue 4, 2010, Pages 301-

Clinical trials legislation - Preparing for the revision of the European directive scheduled for 2011;Législation des essais cliniques: préparer la révision de la Directive Européenne prévue en 2011

Author keywords

Biomedical research; Clinical trials; European Directive; Revision; Risk

Indexed keywords

DATA BASE; DRUG LABELING; DRUG MONITORING; DRUG RESEARCH; DRUG SAFETY; EUROPE; HEALTH CARE ORGANIZATION; HUMAN; LAW; MEDICAL ETHICS; PRIORITY JOURNAL; REVIEW; CLINICAL TRIAL (TOPIC); DRUG INDUSTRY; DRUG LEGISLATION; ETHICS; EUROPEAN UNION; LEGAL ASPECT; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RISK;

EID: 78649655451     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: 10.2515/therapie/2010037     Document Type: Article
Times cited : (5)

References (12)
  • 1
    • 62949145416 scopus 로고    scopus 로고
    • Submission of clinical studies to Ethics Committees or clinical trials registers - The authors' point of view
    • Pehboeck D, Hohlrieder M, Wenzel V. el al. Submission of clinical studies to Ethics Committees or clinical trials registers - the authors' point of view. Intensive Care Med 2009; 35: 713-6
    • (2009) Intensive Care Med , vol.35 , pp. 713-716
    • Pehboeck, D.1    Hohlrieder, M.2    Wenzel, V.3
  • 3
    • 70449699915 scopus 로고    scopus 로고
    • Common definition for categories of clinical research: A prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)
    • Kubiak C, De Andres-Trelles F. Kuchinke W, et al. 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
    • Trials 2009 , vol.10 , pp. 95-101
    • Kubiak, C.1    De Andres-Trelles, F.2    Kuchinke, W.3
  • 5
    • 78649681691 scopus 로고    scopus 로고
    • Clinical Trials Facilitation Group: CTA assessment in member states, 22 December
    • Clinical Trials Facilitation Group: CTA assessment in member states, 22 December 2008. http://www.hma.eu/uploads/media/Assessment- in-MS-public-dec-88- 2-B.pdf.
    • (2008)
  • 6
    • 78649681191 scopus 로고    scopus 로고
    • European Network of Research Ethics Committees (EUREC).
    • European Network of Research Ethics Committees (EUREC). http : //www. eurecnet.org/index.html
  • 7
    • 36549027866 scopus 로고    scopus 로고
    • Adaptation de la mise en oeuvre des bonnes pratiques cliniques en fonction des caractéristiques de certaines recherches
    • 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
    • (2006) Thérapie , vol.61 , pp. 271-277
    • Bertoye, P.H.1    Courcier-Duplantier, S.2    Best, N.3
  • 9
    • 78649645334 scopus 로고    scopus 로고
    • 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)
    • 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
    • (2004)
  • 10
    • 62949122351 scopus 로고    scopus 로고
    • Protocols in expedited review-tackling the workload of Ethics Committees
    • 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
    • (2009) Intensive Care Med , vol.35 , pp. 613-615
    • Wolzt, M.1    Druml, C.2    Leitner, D.3
  • 11
    • 77149136737 scopus 로고    scopus 로고
    • Risk analysis and risk adapted on-site monitoring in non commercial clinical trials
    • Brosteanu O, Houben P, Ihrig K, et al. Risk analysis and risk adapted on-site monitoring in non commercial clinical trials. Clin Trials 2009: 6: 585-96
    • (2009) Clin Trials , vol.6 , pp. 585-596
    • Brosteanu, O.1    Houben, P.2    Ihrig, K.3
  • 12
    • 78649649038 scopus 로고    scopus 로고
    • European Commission. Assessment of the functioning of the Clinical Trials Directive 2001/20/EC: public consultation paperENTR/F/2/SF D 32674. 09/10/2009.
    • European Commission. Assessment of the functioning of the Clinical Trials Directive 2001/20/EC: public consultation paperENTR/F/2/SF D (2009) 32674. 09/10/2009. http://ec.europa.eu/enterprise/sectors/ pharmaceuticals/.iles/ clinicaltrials/docs/2889-18-89- public-consultation-paper.pdf
    • (2009)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.