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Showing 6581–6590 of 43903 articles for “Art. L 227-5”
The resolution college shall ensure compliance by the persons under its jurisdiction with the requirements set pursuant to Article L. 613-44 in coordination with the supervisory college. Where the res…
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…
The provisions 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 (…
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…
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