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Showing 201–210 of 14565 articles for “Art. L112-6”
The procedures for applying this chapter are defined, unless otherwise provided, by decree in the Conseil d'Etat, in particular :1° The conditions for approval, funding, operation and appointment of t…
No performance study may be carried out on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 201…
The procedures for applying the provisions of this chapter are determined by decree in the Conseil d'Etat, and in particular : 1° The composition and conditions of approval, financing, operation and a…
I.-The clinical investigations of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are governed by the provisions of the afo…
I.-For the duration of the clinical investigation involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints whi…
I.-The performance reviews of the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be governed by the provisions of the…
I.-For the duration of the performance study involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which ar…
I.- Unemancipated minors, protected adults or adults who are unable to express their consent and who are not the subject of a legal protection measure shall, when their participation in research invol…
No one may impose restrictions on the rights of individuals or on individual and collective freedoms that are not justified by the nature of the task to be performed or that are not proportionate to t…
For each piece of research mentioned in 1° or 2° of Article L. 1121-1, the dossier submitted to the Committee for the Protection of Individuals and, where applicable, to the competent authority, shall…
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