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Showing 2161–2170 of 65935 articles for “Art. L. 620-1 to L. 628-8”
…may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of the persons undergoing…
…ion on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which are not minimal, the sponsor provides free of charge the medical devi…
…opinion on the conditions for the validity of the clinical investigation, particularly with regard to :the protection of individuals, in particular the protection of participants; -the adequacy, comp…
The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applica…
…of the assessment of the clinical investigation request provided for in Article 62(3) and referred to in Articles 70, 74, 75, 78 and 82 of this Regulation is the National Agency for the Safety of Med…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary…
…minor, this consent is expressed by each of the holders of parental authority. If it is impossible to consult one of the holders of parental authority, the clinical investigation may be carried out p…
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…
…f the Council of 5 April 2017, after he has been given the information provided for in paragraphs 2 to 6 of that same Article. Where it is impossible for the data subject to express his consent in wri…
At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…
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