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Showing 3811–3820 of 50918 articles for “Art. L. 2315-28 to L. 2315-32”
…d of the Council of 5 April 2017 are not being met, it may at any time request that changes be made to the arrangements for carrying out the clinical investigation, to any documents relating to the cl…
…heir liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation…
…n the case of clinical investigations mentioned in the second and third paragraphs of II of Article L. 1125-1, the authorisation of the competent authority; 2° Under conditions contrary to the provisi…
Subject to the provisions of articles L. 1123-15 to L. 1123-20, the provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of a…
Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in clinical investigations which do not involve any risk or constraint. B…
…f dentistry may only be carried 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 carri…
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-…
…initiative of the sponsor must obtain a favourable opinion from the Data Protection Committee prior to its implementation and, in the case of clinical investigations referred to in II of Article L. 11…
…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 Regulation (EU) 2017/745…
…f the Council of 5 April 2017, after he has been given the information provided for in paragraphs 2 to 6 of that same Article. Where it is impossible for the data subject to express his consent in wri…
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