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Showing 2291–2300 of 63264 articles for “Art. L 231-1 u00e0 L 231-5”
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…
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…
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.-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…
For each clinical investigation with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
No clinical investigation may be carried out on a deceased person, in a state of brain death, without his or her consent expressed during his or her lifetime or through the testimony of his or her fam…
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…
No clinical investigation may be carried out on a person without his free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/…
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