EU Introduces Mandatory Harmonised Template for Clinical Trial Recruitment and Informed Consent Under CTR

The European Union has taken a significant step toward streamlining clinical trial documentation with the publication of a new harmonised template for participant recruitment and informed consent procedures. Developed by the MedEthicsEU (搜索)搜索该词条 group—comprising representatives of medical research ethics committees from EU Member States—and endorsed by the Clinical Trials Coordination and Advisory Group (CTAG) (搜索)搜索该词条, the template (Version 2.0) was published in EudraLex Volume 10 and applies to all clinical trials conducted in the EU/EEA under Regulation (EU) 536/2014, the Clinical Trials Regulation (CTR).

The template becomes mandatory for all new Part II submissions from 1 September 2026, with a transition period already in place during which the European Commission recommends its use. It does not apply retrospectively to authorised clinical trials or applications already under assessment.

Addressing a fragmented regulatory landscape

Under the CTR, each clinical trial application is assessed in two parts. Part I covers scientific and product-related elements and is evaluated jointly across participating Member States. Part II addresses national and ethical elements—including participant recruitment and informed consent documentation—and is assessed separately by each Member State concerned. Historically, sponsors have faced considerable challenges because national requirements and expectations vary between Member States, making it difficult to ensure Part II documentation complies with all applicable rules.

The new template aims to create a more consistent approach. It covers six key areas drawn directly from Chapter V of the CTR (Protection of subjects and informed consent) and Annex I, Sections K and L: recruitment procedures, informed consent processes, the inclusion of incapacitated adults (Article 31 CTR), minors (Article 32 CTR), the use of impartial witnesses (Article 29 CTR), and enrolment in emergency situations (Article 34 CTR). Each section includes a dedicated field for additional information relevant to the Member State concerned, enabling national legislative requirements to be addressed within a harmonised structure.

Recruitment procedures under the microscope

Section 1 of the template requires sponsors to articulate how potential participants will be identified and whether that process involves access to identifiable data such as existing patient lists or medical records. The template also prompts sponsors to identify the "first act of recruitment," a concept that marks the start of a clinical trial under Article 2(25) of the CTR. Illustrative examples include approaching potential participants at the clinic, sending a recruitment letter, or posting an advertisement.

Where communication materials are used, sponsors must describe the format—the template explicitly lists paper, electronic or digital forms, artificial intelligence (AI) tools, and video and audio files—as well as how materials will be presented to potential participants and the procedures for handling respondents found not to be eligible. Sponsors must also identify who will make the initial approach, their professional role, whether they have a pre-existing clinical relationship with prospective participants, and whether an external service provider is involved in pre-screening.

Informed consent and decentralised trials

Section 2 addresses the process by which potential participants or their legally designated representatives receive sufficient information to understand the trial and give informed consent, as well as the process by which consent is obtained. Decentralised methods are explicitly addressed: the template asks whether any information is provided using decentralised methods and whether any decentralised elements feature in the consent-capture process itself.

The template does not mandate any particular format for information delivery—written, oral, and video are each listed as options. Sponsors must specify the professional role of the person providing information, whether they have a prior clinical relationship with the participant, the setting in which information is given, and how participant rights are safeguarded, including the right to withdraw, the right to bring a companion, privacy rights, and sufficient time to consider participation.

Vulnerable and special populations

Sections 3 through 6 address populations and circumstances that attract the closest regulatory and ethical scrutiny. Each section is conditional: sponsors complete it only where the trial involves the relevant population or scenario in a given country.

For incapacitated adults (Section 3, referencing Article 31 CTR), the template asks how information will be tailored to the individual's capacity and how that person will be involved in the decision to participate—going beyond a bare reference to legally designated representative consent. For minors (Section 4, referencing Article 32 CTR), sponsors must describe arrangements for obtaining and recording assent—the minor's own agreement to participate, distinct from formal consent of their legal representative—as well as the training and experience of the investigating team in working with children, and the procedure for obtaining informed consent when a participant reaches the age of legal competence.

Section 5 addresses situations where consent must be witnessed by an impartial witness, referencing Article 29 CTR and the ICH E6(R3) good clinical practice standard. Section 6 governs emergency enrolment under Article 34 CTR, requiring justification of why prior consent cannot be obtained, a description of how consent will be sought as soon as possible after enrolment, and the procedure for re-consenting the participant if they subsequently regain capacity.

Implications for sponsors

For sponsors, the new template may offer several benefits: it can help reduce differences in Part II submissions, make preparation more straightforward, and help manage multinational clinical trial applications more efficiently. However, the template's national-requirement fields are likely to call for more country-specific input than has previously been standard in Part II documentation. Where these fields are populated uniformly across Member States without regard to jurisdiction-specific regulatory and ethics committee expectations, there is a risk that the treatment may be considered superficial during assessment.

As noted by Osborne Clarke, recruitment strategy and consent design choices—which have sometimes been treated as operational matters for contract research organisations (CROs) or investigators to manage—may now need to be more explicitly articulated at dossier level by the sponsor and assessed by national ethics committees in terms that go beyond protocol cross-reference. The transition period presents a natural opportunity for sponsors to review internal consent and recruitment standard operating procedures against the content and structure of the new template, particularly where existing procedures were built around the previous template version or around member state-specific models.