{"id":2067,"date":"2024-08-05T13:39:00","date_gmt":"2024-08-05T13:39:00","guid":{"rendered":"https:\/\/beslay-rime.com\/?p=2067"},"modified":"2025-01-17T17:00:54","modified_gmt":"2025-01-17T17:00:54","slug":"publication-des-nouveaux-modeles-de-convention-unique-evolutions-et-implications","status":"publish","type":"post","link":"https:\/\/beslay-rime.com\/en\/publication-des-nouveaux-modeles-de-convention-unique-evolutions-et-implications\/","title":{"rendered":"Publication of new standard agreement templates : developements and implications"},"content":{"rendered":"<p>Here is an overview of the main changes introduced by this <a href=\"https:\/\/www.legifrance.gouv.fr\/jorf\/id\/JORFTEXT000050069546\">order of July 29, 2024.<\/a>.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong><strong>Adaptation to new European regulations<\/strong><\/strong><\/p>\n\n\n\n<p class=\"translation-block\">The new templates incorporate the latest provisions of applicable European regulations, particularly regarding clinical trials of medicinal products, clinical investigations of medical devices, and performance studies of in vitro diagnostic medical devices.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong><strong>Revision of the entire content of the six annexes: focus on the annex regarding costs and additional costs<\/strong><\/strong><\/p>\n\n\n\n<p>In particular, the annex on costs and cost overruns has been amended to reflect increases in existing costs and cost overruns, as well as the introduction of new lines to reflect the increased complexity of studies and specific regulatory requirements (for example: the need to extend the consultation period to obtain informed consent from patients in cases of pregnancy or genetic research). <\/p>\n\n\n\n<p>The update to the cost and additional cost matrix, which reflects cost increases and new research phases, will have a significant impact on the overall project budget. &nbsp;<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong><strong>New optional appendices available<\/strong>&nbsp;<\/strong><\/p>\n\n\n\n<p>New optional appendices have been published: <\/p>\n\n\n\n<ul>\n<li>Appendix 5 \u2013 provision of materials\/equipment;<\/li>\n\n\n\n<li>Appendix 6 \u2013 Provision of biological resources.<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<p>Finally, to assist industry in applying these new models, the Directorate General for Healthcare Provision (DGOS) has published several resources:<\/p>\n\n\n\n<ul>\n<li>An <a href=\"https:\/\/sante.gouv.fr\/IMG\/pdf\/cu_faq_v6_20240929_ri1_ome.pdf\">FAQ<\/a> detailing the new provisions<\/li>\n\n\n\n<li>An <a href=\"https:\/\/sante.gouv.fr\/IMG\/pdf\/ni_2024_120.pdf\">Information Note<\/a> regarding the use of the single agreement for commercial research involving human subjects.<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<p class=\"has-small-font-size\"><em>Written by Klervi Simon<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>On August 3, 2024, updated versions of the standard form for human research were published by an order (\u2018arr\u00eat\u00e9\u2019) dated July 29, 2024. <\/p>","protected":false},"author":1,"featured_media":2095,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.9 - 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