Article R1123-47
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…
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Showing 9041–9050 of 18481 articles for “Art. CE 5-5-2010 n° 301419”
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…
…ious incidents occurring in the course of research mentioned in 1° of Article L. 1121-1, with the exception of those identified in the protocol or in the brochure for the investigator as not requiring…
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…
Once a year for the duration of the research referred to in 1° of Article L. 1121-1 or on request, the sponsor must send the competent authority defined in Article L. 1123-12 and the relevant Data Pro…
The form, content and procedures for reporting adverse reactions and new facts as defined in Article L. 1123-10 and, where applicable, the procedures for lifting the blind shall be laid down by decisi…
The provisions of this section apply without prejudice to the provisions of articles R. 1221-22 to R. 1221-52 relating to haemovigilance.
…rposes of this section, the following definitions shall apply 1° Adverse event, any noxious occurrence in a person who undergoes research involving the human person, whether or not this occurrence is…
…papers and voting materials are printed and sent to each elector; 4° Ensuring that the votes are received; 5° Attending the counting and tallying of votes under the conditions set out in articles R.…
A National Commission for Voting Operations is set up under the Minister for Labour.
The National Commission for Voting Operations comprises :1° Two civil servants appointed by the Minister for Labour, one of whom acts as chairman and the other as secretary ;2° The representatives of…
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