The EU has introduced a new standard template covering recruitment and informed consent procedures. The template was developed by MedEthicsEU, the European Commission’s expert Ethics Committee group, using insights from more than 11,000 clinical trials authorised under the Clinical Trials Regulation.
Informed consent and patient recruitment procedure template: PDF/Word
A new version (v2.0) of the template on recruitment and informed consent procedures is now available and will replace the previous version. The template has been developed by the MedEthicsEU group and endorsed by the Clinical Trials Coordination and Advisory Group (CTAG) with the aim of harmonising Part II templates across EU/EEA. Each section of the template allows for specifying additional information related to the Member State concerned (MSC), i.e. national legislative requirements. The revised template is applicable for all new Part II submissions (i.e. initial, additional MSC, Part II submissions to complete the application in an article 11 submission). This means that it will not be required to implement retrospectively in already authorised trials or trial applications under review. It is highly recommended to use the new version (v2.0) from the date of publication on Eudralex volume 10, however, a transition period is foreseen until full implementation on September 1, 2026.