Brussels, 30 Jul 2003
In preparation for the implementation phase of the EU clinical trials directive, the European Science Foundation (ESF) has developed a training syllabus aimed at harmonising scientific knowledge in the area of clinical studies.
Adopted in May 2001, the EU clinical trails directive lays down provisions regarding the conduct of clinical trials and provides a framework for harmonising the procedure. It also sets out the principles of good clinical practice and makes such provisions legally binding.
The new syllabus is specifically targeted at potential clinical investigators and at helping them to critically evaluate study proposals, conduct studies according to good clinical practices (GCP), and conclude and report valid data as rapidly as possible.
'This Syllabus introduces a better understanding of what the EU Directive will demand from [the researcher] and eventually from all types of intervention studies in the future,' claims ESF.
The programme is also expected to provide sponsors of clinical trials, regulators and ethical committee members, as well as members of scientific and university councils, with a better understanding of the different processes involved.
By reaching all the stakeholders involved in the process, ESF believes that the syllabus will fulfil its objective of defining a common basis for ethical values, and scientific and quality assurance principles covering all types of clinical trials, upon which countries and universities will be able to build individual courses.
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