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Showing 4181–4190 of 62242 articles for “Art. L. 416-1 et seq.”
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…
…terial and technical resources appropriate to the clinical investigation and compatible with the safety requirements of the persons undergoing it. This location must be authorised for this purpose, fo…
…ive and whose promoter or investigator(s) are independent of the companies which manufacture or market the medical devices which are the subject of the clinical investigation. III.The health insurance…
…The total amount of compensation that a person may receive in any one year is limited to a maximum set by the Minister for Health. The payment of such compensation is prohibited in the case of clinica…
…ducts are used in the usual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary for the person not to be able to participate…
…ceased 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 family. However, when the deceased is a minor, this con…
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/…
At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…
…ers, unless, having become aware of them, they did not report them in their report to the general meeting or to the competent body mentioned in Article L. 823-1.
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