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Showing 2931–2940 of 31982 articles for “Art. 10 May 2017”
…so, must set a period of exclusion during which the person who is the subject of the investigation may not participate in another clinical investigation. The length of this period varies according to…
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…
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
…ation is unrelated to their pathological condition. However, the Personal Data Protection Committee may decide in other cases, taking into account the risks and constraints involved in the clinical in…
The competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regula…
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
…icles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a hea…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a personal protection committee and, in the case of clinical inv…
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…
…ersons 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. By…
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