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Showing 6731–6740 of 43956 articles for “Art. L 145-5”
Clinical investigations 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…
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 Data Protection Committee gives its opinion on the conditions for the validity of the clinical investigation, particularly with regard to :the protection of individuals, in particular the prote…
Any promoter whose 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.
Where a clinical investigation is carried out at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate…
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…
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…
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
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