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Showing 3881–3890 of 50918 articles for “Art. L. 2315-28 to L. 2315-32”
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
…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 the in vitro diagnostic medical…
…of the participant and entailing risks and constraints that are not minimal, failure by the sponsor to provide the investigators, free of charge for the duration of the performance study, with the in…
…heir liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article 60 of Regulation…
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 performance studies which do not involve any risk or constraint and in…
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
I.-Natural persons guilty of the offence referred to in article L. 1126-20 shall also be liable to the following penalties: 1° Disqualification from civic, civil and family rights, in accordance with…
Pursuant to Articles 58,66 and 70 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the proje…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Committee for the Protection of Individuals and to the competent authority shall determine wh…
…of the Council of 5 April 2017 are not being met, it may, at any time, request that changes be made to the arrangements for carrying out the performance study, to any documents relating to the perform…
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