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Showing 2421–2430 of 43105 articles for “Art. R. 211-4”
The association's articles of association, funding and organisational and operating conditions must not be such as to limit its independence. In particular, the association's independence must be guar…
The sponsor informs the competent authority and the Committee for the Protection of Individuals without delay of the effective date of commencement of the research, corresponding to the date on which…
The sponsor shall inform the National Commission for Research Involving the Human Person and the National Agency for the Safety of Medicines and Health Products without delay of situations in which it…
Insurance contracts for the research referred to in 1° and 2° of Article L. 1121-1 guaranteeing, under the conditions provided for in Article L. 1121-10, the pecuniary consequences of the civil liabil…
The committees for the protection of individuals comprise thirty-six members divided into two colleges, each with 18 members: 1° The first college is made up of at least: a) Eight people with qualific…
The competent authority defined in Article L. 1123-12 implements the vigilance system relating to research involving the human person. Where necessary, it shall take appropriate measures to ensure the…
…tions and in subsequent reports, the persons involved in the research are identified by a code number. The investigator provides the sponsor with additional information concerning serious adverse even…
For research involving medicinal products, the Director General of the Agence nationale de sécurité du médicament et des produits de santé ensures that all suspected serious unexpected adverse reactio…
The sponsor of a clinical trial, whose application has been submitted under the conditions provided for in 1 of Article 98 of the above-mentioned Regulation of 16 April 2014, may inform the designated…
For the purposes of this section, a secondary establishment is any permanent establishment that is separate from the registered office or principal place of business and is managed by the person requi…
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