Article R1124-2
…l be appointed in accordance with the procedures defined in the first paragraph of II of Article R. 1123-20-1.
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Showing 31–40 of 1215 articles for “Art. s. 1123”
…l be appointed in accordance with the procedures defined in the first paragraph of II of Article R. 1123-20-1.
…ommittee for the Protection of Individuals consulted about the project in application of article L. 1123-6, if the investigator does not already have one; 9° The investigator's brochure referred to in…
…an person in a non-EU country may submit its project to a committee for the protection of individuals.The Committee for the Protection of Individuals gives its opinion on the conditions for the validi…
…information provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. The…
…rrespond to the conditions indicated in the application for authorisation referred to in Article L. 1123-8 or do not comply with the provisions of this Title, it may at any time request that changes b…
When the authority designated in article L. 1123-12 or in II of articles L. 1125-1 and L. 1126-1 does not have agents with the level of clearance required for national defence confidentiality, given t…
…of at least five members, at least two of whom belong to the first college mentioned in article R. 1123-4, comprising at least one person qualified by virtue of their expertise in biostatistics or ep…
…ittee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the measures taken. The sponsor shall inform the Director General…
…o investigational medicinal products in the application for authorisation referred to in Article L. 1123-8 accepted by the Agence nationale de sécurité du médicament et des produits de santé.
…016 L. 1122-1-4 Order no. 2016-800 of 16 June 2016 L. 1122-2 Order no. 2020-232 of 11 March 2020 L. 1123-1 Order no. 2016-800 of 16 June 2016 L. 1123-1-1 Order no. 2016-800 of 16 June 2016 L. 1123-2 L…
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