New harmonised EU template for participant recruitment and informed consent in clinical trials

Under the EU Clinical Trials Regulation ("CTR"), each clinical trial application is assessed in two parts. Part I covers the scientific and product-related elements and is assessed jointly across the participating EU Member States. Part II covers the national and ethical elements (including participant recruitment and informed consent documentation) and is assessed separately by each EU Member State concerned. As national requirements and expectations may vary between EU Member States, sponsors can face challenges in ensuring that Part II documentation complies with all applicable national requirements.

The new template aims to create a more consistent approach to Part II submissions and should be used for fulfilling the requirements of the EU CTR, specifically Chapter V (Protection of subjects and informed consent) and Annex I, Section K (recruitment arrangements) and L (subject information, informed consent form and informed consent procedure). It covers six key areas: recruitment procedures (including the use of digital formats, AI tools and video and audio files for communication material), informed consent processes, the inclusion of incapacitated adults (Article 31 CTR) and minors (Article 32 CTR), the use of impartial witnesses where required (Article 29 CTR) and enrolment in emergency situations (Article 34 CTR). Each section also includes a dedicated field for additional information relevant to the EU Member State concerned. This enables national legislative requirements to be addressed within a harmonised structure.

For sponsors, the new template may offer several benefits. It can help reduce differences in Part II submissions and make preparation more straightforward. It will help sponsors manage multinational clinical trial applications more efficiently.

The new template applies to all new Part II submissions, including initial applications, applications to add an EU Member State Concerned and Part II submissions following an Article 11 application. However, it does not apply retrospectively to authorised clinical trials or applications that are already under assessment.

Sponsors are encouraged to use this template since its publication in EudraLex Volume 10 and to take it into account when planning future submissions. A transition period will remain in place until 1 September 2026, after which its use will become mandatory.

Please contact our team if you have any questions about the new template.

Authored by Hélène Boland.