In brief

On 10 November 2022, the National Coordination Centre for Ethics Committees (“Center”) published the updated versions of the ‘Contract for the performance of clinical trials on medicines’, the ‘Contract for the performance of independent clinical trials on medicines’ and the ‘Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use’.

Key takeaways

In particular, the updates relate to: (i) the expenses borne by the patient (Art. 6.9), in relation to which it is now possible to indemnify the expenses and loss of earnings incurred by the patient and directly related to the participation in the trial/investigation; (ii) the conclusion of the trial (Art. 9.2), by requiring the transmission of the results to the EU database, within one year of its conclusion, regardless of the outcome; (iii) the patenting of inventions (Art. 9.4), where it is specified that the institution may use the investigator’s data and results only for scientific and research purposes and that the promoter’s intellectual property rights should never be jeopardized; (iv) the choice of law (Art. 16.2), which is now left to the parties, although it is recommended to prefer the law of the promoter’s place of business.

Lastly, the Center also published the new template on ‘Contract for conducting clinical investigation to further evaluate the conformity of a CE marked medical device used within its intended use’, which is intended for post-marketing clinical follow-up investigations pursuant to Article 74, Section 1, of Regulation EU 2017/745.