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Showing 4611–4620 of 68654 articles for “Art. L. 123-11 and L. 123-11-1”
At the end of their mandate or the exercise of their functions, the president of the assembly of Martinique or any vice-president, the president of the executive council or any executive councillor wh…
Any breach of the obligation to provide the information mentioned in article L. 111-6 is punishable by an administrative fine of up to €3,000 for a natural person and up to €15,000 for a legal entity.…
No performance study may be carried out 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) 201…
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…
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…
…e 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 are not minimal, the sponsor provides t…
…ordance with paragraphs 2 to 6 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017. Where the performance study concerns the field of maieutics, the…
…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 doss…
…y considers that the requirements set out in Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 are not being met, it may, at any time, request that changes be m…
No performance study 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 family. Ho…
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