Here is an overview of the main changes introduced by this order of July 29, 2024..
Adaptation to new European regulations
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.
Revision of the entire content of the six annexes: focus on the annex regarding costs and additional costs
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).
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.
New optional appendices available
New optional appendices have been published:
- Appendix 5 – provision of materials/equipment;
- Appendix 6 – Provision of biological resources.
Finally, to assist industry in applying these new models, the Directorate General for Healthcare Provision (DGOS) has published several resources:
- An FAQ detailing the new provisions
- An Information Note regarding the use of the single agreement for commercial research involving human subjects.
Written by Klervi Simon
