Abstract
Chapter 6 only includes a brief introduction to the question of which risks, burdens and potential benefits are relevant, and how should they be estimated.
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- 1.
Article 2 (g) of the Clinical Trials Directive defines “investigator’s brochure” as “a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in human subjects”.
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© 2012 Springer Science+Business Media B.V.
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Simonsen, S. (2012). Introduction. In: Acceptable Risk in Biomedical Research. International Library of Ethics, Law, and the New Medicine, vol 50. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2678-9_6
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DOI: https://doi.org/10.1007/978-94-007-2678-9_6
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