[More paper--less research?].
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.
Gögenur
Ismail
I
Amtssygehuset i Gentofte, Kirurgisk-gastroenterologisk Afdeling D, Hellerup. ig@dadlnet.dk
Rosenberg
Jacob
J
D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000592:standards*; D019992:Databases as Topic / Q000592:standards; D035081:Editorial Policies; D017041:Ethics Committees; D006801:Humans; D010506:Periodicals as Topic / Q000592:standards*; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D012189:Retrospective Studies