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Showing 5081–5090 of 41745 articles for “Art. 4 mai 1994”
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…
I. - For associations approved at national level, a financial agreement is concluded under the conditions set out in II of article D. 221-35 of the Social Security Code.II. - For associations approved…
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…
…d) Six representatives of associations approved in accordance with the provisions of article L. 1114-1. Each committee shall include among its members a person qualified in data protection in accorda…
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…
The investigator notifies the sponsor without delay from the day on which he becomes aware of all serious adverse events and all adverse reactions and serious incidents occurring in the course of rese…
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 provisions of this section apply without prejudice to the provisions of articles R. 1221-22 to R. 1221-52 relating to haemovigilance.
In the absence of adaptation, references made by provisions of this code applicable to Saint-Pierre-et-Miquelon, to provisions that do not apply there, are replaced by references to provisions with th…
…formality of registration the deeds and declarations that are subject to it pursuant to Article L. 141-5.
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