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Showing 2381–2390 of 50210 articles for “Art. L. 2315-82 to L. 2315-96”
Before a clinical investigation 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 i…
…ns of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (EU) 2016/679…
…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…
…hose civil liability is not covered by the insurance provided for in the third paragraph of article L. 1125-9 shall be punished by one year's imprisonment and a fine of 15,000 euros.
…des or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate in advance to the pharmacist managing this pharmacy the data relating to clinical inv…
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…
I.-Natural persons guilty of the offence referred to in article L. 1125-21 shall also be liable to the following penalties: 1° disqualification from civic, civil and family rights, in accordance with…
…part in it and for that of his successors, unless he can prove that the damage is not attributable to his fault or to the fault of any other party involved, without it being possible to invoke the ac…
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