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Showing 2311–2320 of 63264 articles for “Art. L 231-1 u00e0 L 231-5”
…he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scientific purposes. The person may withdraw their consent to this subsequent use or ex…
I.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the prot…
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
I.-For the duration of the performance study 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 which ar…
…son taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this information is provided by that person or by another qualified person representi…
For each study of performance, 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…
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the per…
…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 family. However, where the deceased person is a mino…
…on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of…
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