In brief

On 31 May 2022, the National Coordination Centre of Ethics Committees (NCCEC) updated the templates for the conduct of clinical trials on medicinal products and clinical investigations on medical devices that identify the minimum content of the agreement between sponsors/CROs and clinical sites to ensure the uniformity of administrative, economic and insurance aspects.

Key takeaways

  • The most significant changes compared to the previous versions include the provision that any changes and/or additions to the template approved by the NCCEC must be justified by the specificity and peculiarities of the individual clinical trial and explained within the agreement. Regarding conflicts of interests, the new templates introduce specific reporting obligations for the investigator through an express reference to Article 6, paragraph 4, of Legislative Decree No. 52/2019, pursuant to which the latter must declare to the healthcare structure they work for their own financial interests, and those of their spouse and cohabiting partner with respect to the trial, and any employment, consultancy or collaboration relationships with the sponsor, as well as the absence of any participation in the share capital of the company holding the investigational drug.
  • A further change refers to the law governing the agreement. Compared to the previous versions that only provided for the Italian law, the new templates defer to the parties for the choice of the governing law, without any prejudice to mandatory Italian rules concerning the protection of patients’ rights.
  • Lastly, the templates for the conduct of non-profit clinical trials on medicinal products clarify that the arrangements for the assignment and transfer of clinical data and results for registration purposes or the development of the investigational drug must comply with the conditions set out in Article 3 of the Decree of the Ministry of Health dated 30 November 2021, and that the value of the assets to be transferred must take into account the support of the public clinical sites with regards to the design and development of the data and/or results being transferred.