-
1
-
-
33644899089
-
Harmful impact of EU Clinical Trials Directive
-
Hemminki A. Harmful impact of EU Clinical Trials Directive. Br Med J 2006;332:501-2.
-
(2006)
Br Med J
, vol.332
, pp. 501-502
-
-
Hemminki, A.1
-
2
-
-
49249094300
-
Conducting a European multi-centre trial: first experiences with the new European Clinical Trials Directive from an academic perspective
-
Delawi D, Dhert WJA, Oner FC. Conducting a European multi-centre trial: first experiences with the new European Clinical Trials Directive from an academic perspective. Eur Spine J 2008;17:1113-15.
-
(2008)
Eur Spine J
, vol.17
, pp. 1113-1115
-
-
Delawi, D.1
Dhert, W.J.A.2
Oner, F.C.3
-
3
-
-
33846020021
-
The impact of the 'clinical trials' directive on the cost and conduct of non-commercial cancer trials in the UK
-
Hearn J, Sullivan R. The impact of the 'clinical trials' directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Cancer 2007;43:8-13.
-
(2007)
Eur J Cancer
, vol.43
, pp. 8-13
-
-
Hearn, J.1
Sullivan, R.2
-
4
-
-
77956092706
-
-
Impact on Clinical Research of European Legislation (ICREL) project final report. February
-
Impact on Clinical Research of European Legislation (ICREL) project final report. February 2009. http://www.efgcp.be/Downloads/EFGCP%20Annual% 20Report%20of%20Activities%202009.pdf.
-
(2009)
-
-
-
5
-
-
0003177157
-
Directive 2001/20/EC of the European Parliament and Council of 4th April 2001
-
European Parliament
-
European Parliament. Directive 2001/20/EC of the European Parliament and Council of 4th April 2001. Official Journal of the European Communities 2001;121:34-44.
-
(2001)
Official Journal of the European Communities
, vol.121
, pp. 34-44
-
-
-
6
-
-
77956068285
-
-
Law of 7 May 2004 concerning experiments on the human person: Loi relative aux Expérimentations sur la Personne Humaine (LEH)
-
Law of 7 May 2004 concerning experiments on the human person: Loi relative aux Expérimentations sur la Personne Humaine (LEH). http://www.fagg-afmps.be/en/binaries/law-2004-05-07_tcm292-27420.doc.
-
-
-
-
7
-
-
77956076881
-
-
154th Act of 1997 on health-care: 1997. évi CLIV. törvény az egészségügyro{double acute}
-
154th Act of 1997 on health-care: 1997. évi CLIV. törvény az egészségügyro{double acute}.
-
-
-
-
8
-
-
77956079809
-
-
Research Involving Human Subjects Act (WMO)
-
Research Involving Human Subjects Act (WMO) 1998. http://www.healthlaw.nl/humsub.pdf.
-
(1998)
-
-
-
9
-
-
77956066254
-
-
Health Research Act: Act 20-06-2008 No. 44
-
Health Research Act: Act 20-06-2008 No. 44.
-
-
-
-
10
-
-
77956084448
-
-
Royal Decree 223/2004 of 6 February, on clinical trials involving medicinal products: Real Decreto 223/2004, de 6 de febrero, por el que se regulan los ensayos clínicos con medicamentos
-
Royal Decree 223/2004 of 6 February, on clinical trials involving medicinal products: Real Decreto 223/2004, de 6 de febrero, por el que se regulan los ensayos clínicos con medicamentos. http://www.eurecnet.org/information/spain.html.
-
-
-
-
11
-
-
77949482007
-
Nonurgent patients in the emergency department? A French formula to prevent misuse
-
Stéphanie Gentile, Pascal Vignally, Anne-Claire Durand, et al. Nonurgent patients in the emergency department? A French formula to prevent misuse. BMC Health Services Research 2010;10:66.
-
(2010)
BMC Health Services Research
, vol.10
, pp. 66
-
-
Gentile, S.1
Pascal, V.2
Durand, A.-C.3
-
12
-
-
77956092394
-
-
Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460; updated in SFS 2008:192)
-
Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460; updated in SFS 2008:192).
-
-
-
-
13
-
-
77949504169
-
-
The European Communities (Clinical Trials on Medicinal Products for Human Use)
-
The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004.
-
(2004)
Regulations
-
-
-
14
-
-
77956093691
-
-
The Medical Research Act 488/1999 (amended by 295/2004)
-
The Medical Research Act 488/1999 (amended by 295/2004)
-
-
-
-
15
-
-
77956076455
-
-
Adults With Incapacity (Scotland) Act
-
Adults With Incapacity (Scotland) Act 2004
-
(2004)
-
-
-
16
-
-
77956084007
-
-
The Mental Capacity Act
-
The Mental Capacity Act 2005
-
(2005)
-
-
-
17
-
-
77956093262
-
-
The Medicines Act (Arneimittelgesetz) of 1983, last amended in 2008 (BGBI. I Nr. 115/2008)
-
The Medicines Act (Arneimittelgesetz) of 1983, last amended in 2008 (BGBI. I Nr. 115/2008).
-
-
-
-
18
-
-
77956077359
-
-
The German Drug Act (Arzneimittelgesetz; AMG)
-
The German Drug Act (Arzneimittelgesetz; AMG).
-
-
-
-
19
-
-
77956079062
-
-
Legislative decree no. 211 of June 24 2003
-
Legislative decree no. 211 of June 24 2003.
-
-
-
-
21
-
-
77956073977
-
-
The EFGCP Report on the Procedure for Ethical Review of Protocols for Clinical Research Projects in the European Union. November 2006
-
The EFGCP Report on the Procedure for Ethical Review of Protocols for Clinical Research Projects in the European Union. November 2006. http://www.efgcp.be/Downloads/EFGCPReportFiles/Italy%202010.pdf.
-
-
-
-
22
-
-
77956088771
-
-
The Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research Projects no. 402 of 28 May 2003 (amended in Act No. 272 1 of April 2006)
-
The Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research Projects no. 402 of 28 May 2003 (amended in Act No. 272 1 of April 2006).
-
-
-
-
23
-
-
10744230615
-
The European directive: a further blow to intensive care medicine in Austria
-
Druml C, Singer EA. The European directive: a further blow to intensive care medicine in Austria. Intensive Care Med 2004;30:335.
-
(2004)
Intensive Care Med
, vol.30
, pp. 335
-
-
Druml, C.1
Singer, E.A.2
-
24
-
-
0036272427
-
A serious threat to evidence based resuscitation within the European Union
-
Sterz F, A Singer E, Böttiger B, et al. A serious threat to evidence based resuscitation within the European Union. Resuscitation 2002;53:237-8.
-
(2002)
Resuscitation
, vol.53
, pp. 237-238
-
-
Sterz, F.1
Singer, A.2
Böttiger, B.3
-
25
-
-
18744409613
-
The European directive on clinical research: present status of implementation in EU member states' legislations with regard to the incompetent patient
-
Lemaire F, Bion J, Blanco J, et al. The European directive on clinical research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med 2005;31:476-9.
-
(2005)
Intensive Care Med
, vol.31
, pp. 476-479
-
-
Lemaire, F.1
Bion, J.2
Blanco, J.3
-
26
-
-
33645839880
-
The European Clinical Trials Directive revisited: the VISEAR recommendations
-
Liddell K, Chamberlain D, Menon DK, et al. The European Clinical Trials Directive revisited: the VISEAR recommendations. Resuscitation 2006;69:9-14.
-
(2006)
Resuscitation
, vol.69
, pp. 9-14
-
-
Liddell, K.1
Chamberlain, D.2
Menon, D.K.3
-
27
-
-
34748863659
-
Evaluating benefits and harms in intensive care research
-
Weijer C, Miller PB. Evaluating benefits and harms in intensive care research. Intensive Care Med 2007;33:1819-22.
-
(2007)
Intensive Care Med
, vol.33
, pp. 1819-1822
-
-
Weijer, C.1
Miller, P.B.2
-
28
-
-
62949122351
-
Protocols in expedited review: tackling the workload of ethics committees
-
Woltz M, Druml C, Leitner D, et al. Protocols in expedited review: tackling the workload of ethics committees. Intensive Care Med 2009;35:613-15.
-
(2009)
Intensive Care Med
, vol.35
, pp. 613-615
-
-
Woltz, M.1
Druml, C.2
Leitner, D.3
-
29
-
-
4344714862
-
Breast cancer research and the European union Clinical Trials Directive
-
Williams N. Breast cancer research and the European union Clinical Trials Directive. Breast Cancer Res 2004;6:145-7.
-
(2004)
Breast Cancer Res
, vol.6
, pp. 145-147
-
-
Williams, N.1
-
30
-
-
77956076285
-
-
The European Science Foundation. March
-
The European Science Foundation. Forward Look: Investigator-driven clinical trials. March 2009. http://www.esf.org/activities/forward-looks/medical-sciencesemrc/fl-07-001-investigator-driven-clinical-trials.html.
-
(2009)
Forward Look: Investigator-driven clinical trials
-
-
-
31
-
-
14944375041
-
Collateral damage or apocalypse now for European academic research
-
Singer EA, Druml C. Collateral damage or apocalypse now for European academic research. Intensive Care Med 2005 31:271.
-
(2005)
Intensive Care Med
, vol.31
, pp. 271
-
-
Singer, E.A.1
Druml, C.2
-
32
-
-
10244255015
-
Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive
-
Druml C. Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive. Curr Opin Crit Care 2004;10:570-3.
-
(2004)
Curr Opin Crit Care
, vol.10
, pp. 570-573
-
-
Druml, C.1
-
33
-
-
33750529955
-
Medical research involving incapacitated adults: implications of the EU Clinical Trials Directive 2001/20/EC
-
Liddel K, Bion J, Chamberlain D, et al. Medical research involving incapacitated adults: implications of the EU Clinical Trials Directive 2001/20/EC. Med Law Rev 2006;14:367-417.
-
(2006)
Med Law Rev
, vol.14
, pp. 367-417
-
-
Liddel, K.1
Bion, J.2
Chamberlain, D.3
-
36
-
-
38149018609
-
Effect of the European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006
-
Berendt L, Håkansson C, Bach KF, et al. Effect of the European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006. Br Med J 2008 336:33-5.
-
(2008)
Br Med J
, vol.336
, pp. 33-35
-
-
Berendt, L.1
Håkansson, C.2
Bach, K.F.3
-
37
-
-
34250362785
-
The EU Clinical Trials Directive: 3 years on
-
Hoey R. The EU Clinical Trials Directive: 3 years on. Lancet 2007;369:1777-8.
-
(2007)
Lancet
, vol.369
, pp. 1777-1778
-
-
Hoey, R.1
-
38
-
-
77956093420
-
-
Medical Research Council Clinical Trials toolkit
-
Medical Research Council Clinical Trials toolkit. http://www.ct-toolkit.ac.uk
-
-
-
|