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Showing 71–80 of 83 articles for “Art. 745”
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
For each clinical investigation with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
No clinical investigation may be carried out on a deceased person, in a state of brain death, without his or her consent expressed during his or her lifetime or through the testimony of his or her fam…
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
With a view to the application of the provisions of the first paragraph of article L. 1125-6 and article L. 1125-7, a national register shall be kept of persons who are free of any disease and who vol…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a personal protection committee and, in the case of clinical inv…
Subject to the provisions of articles L. 1123-15 to L. 1123-20, the provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of a…
Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in clinical investigations which do not involve any risk or constraint. B…
Clinical investigations in the field of dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Clinical investigations in th…
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