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- W2023639462 abstract "The regulatory framework of clinical research in France was recently modified substantially, in part to transpose into French law directive 2001/20/EC of the European Parliament and Council, which concerns only drug trials. The revision also covered research on human beings (Public Health L. 2004-806, 2006-450), on biological samples (revision of bioethics, L. 2004-800) and on data (the so-called CNIL act, L. 2004-801). The value of this set of texts (statutes, decrees, and regulations) is that it diversifies and clarifies the different forms of clinical research.This article describes the painful progression of important public health studies, most often with academic sponsors.The 5 studies described here managed to overcome a variety of obstacles posed by the pre-2004 regulations.To understand the new provisions, it is useful to recall the difficulties, imprecision and inaptness of the earlier regulations." @default.
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- W2023639462 date "2007-09-01" @default.
- W2023639462 modified "2023-09-30" @default.
- W2023639462 title "Nouvelle législation portant sur les soins courants: rappel des difficultés passées" @default.
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- W2023639462 doi "https://doi.org/10.1016/j.lpm.2007.02.033" @default.
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