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
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;
CLINICAL TRIALS AS TOPIC;
DRUG INDUSTRY;
ETHICS COMMITTEES, RESEARCH;
EUROPE;
EUROPEAN UNION;
GUIDELINES AS TOPIC;
HUMANS;
LEGISLATION, DRUG;
RISK;
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
European Forum for Good Clinical Practice (EFGCP).Conference on the Impact on Clinical Research of European Legislation (FP7 program. ICREL), results S discussion, Brussels 2 Dec 2008. http://www.efgcp. be/Downloads/confDocuments/Programme-ICREL-2-Dec-2888- final.pdf
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
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
European Network of Research Ethics Committees (EUREC).
European Network of Research Ethics Committees (EUREC). http : //www. eurecnet.org/index.html
7
36549027866
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
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. u-bordeaux2.fr/optimon/Documents.aspx
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
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
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
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.