Article L1152-2
…good faith, reported or witnessed such acts may be subject to the measures mentioned in Article L. 1121-2. The persons mentioned in the first paragraph of this article benefit from the protections pr…
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Showing 111–120 of 187 articles for “Art. 1121”
…good faith, reported or witnessed such acts may be subject to the measures mentioned in Article L. 1121-2. The persons mentioned in the first paragraph of this article benefit from the protections pr…
I.-As part of the research referred to in Article L. 1121-1, the clinical investigations referred to in Article L. 1125-1 and the performance studies referred to in Article L. 1126-1, the internal-use…
…her duties, or who has reported such facts, may be subject to the measures mentioned in Article L. 1121-2. The persons mentioned in the first paragraph of this article benefit from the protection pro…
…legislative and regulatory provisions in force or of the good practices provided for in Article L. 1121-3 which are likely to compromise the safety of the persons taking part in this research or the…
…rts organs for therapeutic purposes, including biomedical research within the meaning of Article L. 1121-1, shall ensure that these organs have been removed in compliance with standards of protection…
…efits and risks and the soundness of the conclusions for the research mentioned in 1° of Article L. 1121-1 and not involving a product mentioned in Article L. 5311-1 and for the research mentioned in…
…ing to elements retained at the end of research involving the human person as defined in Article L. 1121-1.
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…
…o post-authorisation safety studies of a non-interventional nature within the meaning of Article R. 1121-2, which give rise to the collection of safety information from patients or healthcare professi…
For the research referred to in 1° of Article L. 1121-1 involving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse…
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