Gögenur Ismail, Rosenberg Jacob
Amtssygehuset i Gentofte, Kirurgisk-gastroenterologisk Afdeling D, Hellerup.
Ugeskr Laeger. 2006 Oct 16;168(42):3609-12.
Since the implementation of EU directive 2001/20/EF in May 2004, clinical research has become increasingly complicated to perform. The legal requirements are extensive with the result that clinical researchers find themselves spending more and more time on administrative procedures. The consequences will probably be that the amount of research will decline as a result of the new laws. We describe what the basic requirements for clinical researchers are today.
自2004年5月欧盟第2001/20/EF号指令实施以来，临床研究的开展变得日益复杂。法律要求繁多，导致临床研究人员发现自己在行政程序上花费的时间越来越多。新法律的结果可能是研究数量会减少。我们阐述了如今对临床研究人员的基本要求。
