Literature DB >> 14751874

Implementing the European clinical trials directive.

Kent Woods.   

Abstract

Keywords:  Biomedical and Behavioral Research; Legal Approach; National Health Service

Mesh:

Year:  2004        PMID: 14751874      PMCID: PMC324443          DOI: 10.1136/bmj.328.7434.240

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


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  5 in total

1.  The death of academic clinical trials.

Authors:  Alyn H Morice
Journal:  Lancet       Date:  2003-05-03       Impact factor: 79.321

2.  Who's afraid of the European clinical trials Directive?

Authors: 
Journal:  Lancet       Date:  2003-06-28       Impact factor: 79.321

3.  European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287.

Authors:  David J Flavell; Sopsamorn U Flavell; Richard Sullivan
Journal:  Lancet       Date:  2003-10-25       Impact factor: 79.321

4.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

5.  European Organisation for Research and Treatment of Cancer's point of view.

Authors:  Françoise Meunier; Denis Lacombe
Journal:  Lancet       Date:  2003-08-23       Impact factor: 79.321

  5 in total
  8 in total

1.  Another threat to research in the United Kingdom.

Authors:  Richard Nicholson
Journal:  BMJ       Date:  2004-05-22

2.  New European clinical trials directive: implementation requires funding for effective training programmes.

Authors:  Allan Gaw; Moira M B Mungall
Journal:  BMJ       Date:  2004-02-28

Review 3.  Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?

Authors:  L Sheard; C N E Tompkins; N M J Wright; C E Adams
Journal:  J Med Ethics       Date:  2006-07       Impact factor: 2.903

4.  Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries.

Authors:  Markus Hartmann
Journal:  Trials       Date:  2012-04-29       Impact factor: 2.279

5.  Clinical trials and tribulations.

Authors:  P H Canter; E Ernst
Journal:  J R Soc Med       Date:  2004-03       Impact factor: 18.000

6.  Tissue Engineering Stem Cells - An e-Governance Strategy.

Authors:  Simon Grange
Journal:  Open Orthop J       Date:  2011-07-28

7.  The unintended consequences of clinical trials regulations.

Authors:  Alex D McMahon; David I Conway; Tom M Macdonald; Gordon T McInnes
Journal:  PLoS Med       Date:  2009-11-17       Impact factor: 11.069

8.  Conducting a European multi-center trial: first experiences with the new EU Clinical Trials Directive from an academic perspective.

Authors:  Diyar Delawi; Wouter J A Dhert; F Cumhur Oner
Journal:  Eur Spine J       Date:  2008-06-13       Impact factor: 3.134

  8 in total

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