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Showing 6471–6480 of 67137 articles for “Art. L. 145-11 + Art. R. 145-1”
…cular:1° A reproduction of the clauses and information in the secondment contract listed in article L. 1251-43 ; 2° The employee's professional qualifications;3° The terms and conditions of the remune…
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…
…ations under the following conditions: 1° Medical devices included on the list mentioned in article L. 165-1 of the Social Security Code or covered by the hospitalisation benefits mentioned in article…
…lusions for clinical investigations not covered by the second and third paragraphs of II of article L. 1125-1 ; -the appropriateness of the objectives pursued and the resources deployed; -the qualific…
…f expenses incurred and, where applicable, compensation for constraints suffered paid by the promoter. The total amount of compensation that a person may receive in any one year is limited to a maximu…
…e governed by the provisions of the aforementioned Regulation (EU) and the provisions of this chapter. II-The competent authority for carrying out the scientific examination as part of the assessment…
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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