Global core competencies for clinical trials

2012 
728 www.thelancet.com Vol 380 August 25, 2012 methodological training for members of the trial team and for research ethics committee members. Kenter and Cohen request that trial applications be reviewed by competent experts, while acknow ledging that such expertise is unlikely to be evenly distributed within the EU. They do not suggest how this gap should be fi lled. This challenge has been a major issue for one of the subgroups of our OECD Global Science Forum Working Group. We recommend the development of global core competencies as a compendium of required knowledge and skills for investigators and other members of the clinical trials team, research ethics committees, regulatory bodies, and sponsors. These training programmes should be open to the general public. Standardised, internationally recognised accredited qualifi cations in patient-oriented research should be defi ned in connection with these competencies. In this way, we can improve the training of everybody involved in clinical trials.
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