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Showing 6911–6920 of 49555 articles for “Art. L. 125-5 V + jurisprudence”
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 competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regula…
…iament and of the Council of 5 April 2017, on the communication of information intended to be made available to the public in the electronic system provided for in Article 73 of the aforementioned Reg…
Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not come under the provisions of Art…
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…
…l 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. By way of derogation, the Data Protection…
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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