After submission of the application for clinical trial assessment defined in Article 5(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2004, a Data Protection Committee shall be appointed in accordance with the procedures defined in the first paragraph of II of Article R. 1123-20-1.
Après le dépôt de la demande d’évaluation d’essai clinique définie au 1 de l’article 5 du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2004, un comité de protection des personnes est désigné selon les modalités définies au premier alinéa du II de l’article R. 1123-20-1.
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75001, Paris France
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