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Showing 3471–3480 of 9058 articles for “Art. CE 24-11-2017 n° 396209”
…hemselves to clinical investigations that do not involve any risk or constraint and in which all procedures are performed and products used in the usual way. They may only be asked to take part in oth…
…nt authority; 2° Under conditions contrary to the provisions of article L. 1125-11; 3° The performance of which has been prohibited or suspended by the competent authority. Any investigator who carrie…
…e provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of article 413-9 of the French Criminal Code.
…scheme or who is a beneficiary of such a scheme to take part in clinical investigations, with the exception of those which do not involve any risk or constraint and in which all the procedures are per…
…ed out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Clinical investigations in the field of midwifery may only be carried out under the direction an…
Performing or having performed a clinical investigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-…
Once the Data Protection Committee has issued a favourable opinion and the investigation has been authorised by the Agence nationale de sécurité du médicament et des produits de santé, where applicabl…
The provisions of Articles 72, 75, 76, 77, 80, 87, 88, 89 and 90 of the aforementioned Regulation (EU) shall apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulatio…
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/…
…data protection committee appointed at random from among the committees available and having the necessary competence to examine the project, under the conditions provided for in Article L. 1123-14 o…
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