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Showing 701–710 of 52948 articles for “Art. CE 27-1-2017 n° 391817”
…to risks and constraints which are not minimal, the sponsor provides free of charge the medical devices which are the subject of the clinical investigation. II - Non-commercial clinical investigations…
…e adequacy, completeness and comprehensibility of the written information to be provided and the procedure to be followed to obtain informed consent, and the justification for conducting a clinical in…
…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 maximum set by the Minister for Health. The payment of such co…
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/…
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…
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
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