Who's afraid of the European Clinical Trials Directive?
2003; Elsevier BV; Volume: 361; Issue: 9376 Linguagem: Inglês
10.1016/s0140-6736(03)13781-6
ISSN1474-547X
Autores Tópico(s)Health Systems, Economic Evaluations, Quality of Life
ResumoWouldn't it be nice if the approval and monitoring of clinical research done in the many, varied, and ever-increasing number of European countries could be simplified and streamlined? This deceptively simple idea was first mooted well over a decade ago and by 1995 the European Commission had published a concept paper for a European Directive on Implementing Good Clinical Practice. Several complex rounds of negotiation between the various European legislative bodies followed and the result, Directive 2001/20/EC, was officially adopted on April 4, 2001.
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