ESF Syllabus for Clinical Investigator Training

ESF wishes to introduce this Syllabus to help create a culture of scientifically knowledgeable physicians: physicians who, in view of the EU Clinical Trial Directive, would be able to critically evaluate study proposals, to conduct studies according to Good Clinical Practice (GCP), and to conclude and report valid data as rapid and safe as possible. The way to achieve this is through education and training, and ESF is now setting the scientific aim for this.

With the new countries entering the EU, the mission of establishing a standard for training and education is getting even more important. In view of the many courses now emerging as a response to the Clinical Trial Directive, some good and relevant, other courses more light-weighted, there is really a need for the ESF Syllabus, the new standard in Clinical Investigator Training.

The ESF Syllabus for Clinical Investigator Training is an attempt to form a common ground of values and knowledge for the physician’’s basic need when entering the field of clinical studies. Also to the more experienced researcher albeit less familiar to GCP, this Syllabus introduces a better understanding what the EU Directive will demand from him and eventually from all types of intervention studies in the future.

The Syllabus will be of great use for the researcher, but also for sponsors in achieving a well- trained study team. For researchers who become their own sponsors the Syllabus will cover their need and create understanding to the process. For regulators and Ethical Committee members it will act as a natural starting ground in evaluating study proposals. For universities and scientific councils it will provide the net values to be included in any course, and the minimum qualification level for any holder of a clinical research grant.

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Jens Degett alfa

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