New European Directive on clinical trials [3]

Lancet

Volumn 361, Issue 9367, 2003, Pages 1473-

  Stocchetti, Nino ^a   Dearden, Mark ^b   Karimi, Abbi ^c   Lapierre, Francoise ^m   Maas, Andrew ^d   Murray, Gordon D ^e   Ohman, Juha ^f   Persson, Lennart ^g   Sahuquillo, Juan ^h   Servadei, Franco ⁱ   Teasdale, Graham ^j   Trojanowski, Tomasz ^k   Unterberg, Andreas ^l  

^a UNIVERSITY OF MILAN   (Italy)

^b Leeds General Hospital   (United Kingdom)

^c UNIVERSITY OF COLOGNE   (Germany)

^d ERASMUS MEDICAL CENTER   (Netherlands)

^e UNIVERSITY OF EDINBURGH   (United Kingdom)

^f HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^g UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^h HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

ⁱ BUFALINI HOSPITAL   (Italy)

^j UNIVERSITY OF GLASGOW   (United Kingdom)

^k MEDICAL UNIVERSITY OF LUBLIN   (Poland)

^l HUMBOLDT UNIVERSITY   (Germany)

^m NONE

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Author keywords

[No Author keywords available]

Indexed keywords

BRAIN INJURY; CLINICAL RESEARCH; CLINICAL TRIAL; EUROPE; HUMAN; INFORMED CONSENT; LETTER; MEDICAL ETHICS; MEDICOLEGAL ASPECT; METHODOLOGY; MORBIDITY; MORTALITY; PATIENT RIGHT; PRIORITY JOURNAL; BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH; LEGAL ASPECT;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

CLINICAL TRIALS; EUROPE; HUMANS; INFORMED CONSENT;

EID: 0242317403     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(03)13115-7     Document Type: Letter

References (4)

1. 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. Official Journal of the European Communities 1-5-2001, L 121/34-44.
2. Faden A.I. Neuroprotection and traumatic brain injury: the search continues. Arch Neurol. 58:2001;1553-1555.
3. Chesnut R.M., Marshall L.F., Klauber M.R., et al. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 34:1993;216-222.
4. Murray G.D., Teasdale G.M., Braakman R., et al. The European Brain Injury Consortium survey of head injuries. Acta Neurochir. 141:1999;223-236.