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Showing 2871–2880 of 61415 articles for “Art. 325-5 and 325-6”
…concerne les personnes mentionnées aux 1° et 2° de l'article R. 814-58-6.II. - The rights of access and rectification provided for in articles 39 and 40 of this same law may be exercised with the Cons…
If there is a change in the designation of the accounting officer or in the terms of settlement of the contract, the purchaser shall annotate the single copy or the certificate of transferability with…
For all research involving humans, the sponsor must pass on to the investigators concerned any information likely to affect the safety of individuals.
The sponsor shall keep detailed records of all adverse events notified to it by the investigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at i…
…ent et des produits de santé any suspected serious unexpected adverse reactions occurring in France and outside national territory within the following time limits:1° In the case of a serious unexpect…
The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the…
For the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et…
…cament et des produits de santé any adverse reaction occurring in a person undergoing such research and any serious incident occurring in France and outside national territory without delay from the d…
…he Agence nationale de sécurité du médicament et des produits de santé any serious adverse reaction and any serious incident occurring in France and outside national territory in the research it is co…
For the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the investigator who has knowledge…
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