French Public Health Code
In forceOnce the Committee for the Protection of Individuals has issued a favourable opinion and the performance study has been authorised, where applicable, by the Agence nationale de sécurité du médicament et des produits de santé, any substantial modification at the initiative of the sponsor must obtain a favourable opinion from the Committee for the Protection of Individuals prior to its implementation and, in the case of performance studies mentioned in the second to fifth paragraphs of II of Article L. 1126-1, where applicable, authorisation from the competent authority in accordance with the provisions of II of the same article. In this case, the committee shall ensure that a new consent is obtained from the persons participating in the performance study, if this is necessary.
When the validation is carried out by the Data Protection Committee in application of IV of Article L. 1126-1 and the request for substantial modification gives rise to serious doubt as to the qualification of the performance study, the Data Protection Committee concerned shall refer the matter to the Agence nationale de sécurité du médicament et des produits de santé.
In the event of an unfavourable opinion from the committee, the sponsor may request that its proposed substantial amendment be submitted for a second examination to another committee for the protection of individuals under conditions defined by decree in the Conseil d'Etat.
