EU introduces harmonised template for clinical trial recruitment and consent

The European Commission's expert ethics committee group MedEthicsEU has released a revised template for clinical trial recruitment and informed consent procedures as part of volume 10 of EudraLex, the EU's rules governing medicinal products.

Endorsed by the EU Clinical Trials Coordination and Advisory Group (CTAG), the template is designed to harmonise how sponsors document Part II recruitment and consent arrangements across the EU and European Economic Area for clinical trials authorised under Regulation (EU) 536/2014 (CTR). The arrival of the template consolidates what has been a fragmented landscape in which national Part II expectations have varied considerably across member states. It formalises a single six-section structure that should now be used for all new submissions. The CTR itself may be subject to further change if and when the proposed EU Biotech Act becomes law.

Recruitment guidelines

Section 1 of the template requires sponsors to articulate, in concrete terms, how potential participants will be identified and whether that process involves access to identifiable data such as existing patient lists or medical records. The distinction between identification that involves access to identifiable data, such as existing patient lists or medical records that the template explicitly mentions, and approaches that do not may carry different implications under national data protection regimes.

The template also prompts sponsors to identify the first act of recruitment under section 1.2, a concept that matters as it 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; the choice between them is not merely operational, as it determines the moment from which certain regulatory requirements run.

Where communication materials are used, sections 1.3 and 1.4 require sponsors to describe the format. The template explicitly lists paper and electronic or digital forms, artificial intelligence (AI) tools, video and audio files. They also need to describe how the material will be presented to potential participants (for example via post, in the clinic or through social media), and the procedures for handling respondents found not to be eligible, in line with annex I of the CTR. Section 1.5 requires sponsors to 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.

The national-requirement field at section 1.6 invites sponsors to specify any additional information relevant to member state rules on recruitment procedure, including national legislation. It accommodates the divergence that may occur across jurisdictions on matters such as recruitment practices and direct outreach. Sponsors planning multi-country trials may wish to assess, per jurisdiction, whether existing internal recruitment processes already capture what each relevant national ethics committee will expect to see in this field.

Informed consent and decentralised trials

Section 2 of the template addresses two related but distinct obligations. Section 2.1 concerns the process by which potential participants or their legally designated representative where applicable, are provided with sufficient information to understand the trial and give informed consent. Section 2.2 concerns the process by which that consent is then obtained. 

Decentralised methods are explicitly addressed throughout the section: 2.1 asks whether any information is provided using decentralised methods, while 2.2 asks whether any decentralised elements feature in the consent-capture process itself. 

The template does not mandate any particular format for that information: written, oral and video are each listed as options under section 2.1. Sponsors must specify, however, the professional role of the person providing the information and 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. Section 2.2 adds parallel requirements for the consent stage, including whether any decentralised elements are involved.

For sponsors whose trial design incorporates technology-enabled information delivery or consent tools, these prompts create a practical incentive to describe those tools and their role in the Part II dossier, rather than addressing them solely at protocol level.

Vulnerable and special populations

Sections 3 to 6 of the template 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 of the 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. This goes beyond a bare reference to legally designated representative consent.

For minors (section 4, in reference to article 32 of the CTR), the template asks sponsors to describe arrangements for obtaining and recording assent; that is, the minor's own agreement to participate, distinct from the formal consent of their legally designated representative. It also asks for a description of the training and experience of the investigating team in working with children, and, at section 4.3, the procedure for obtaining informed consent when a participant reaches the age of legal competence, a point the template cross-references to question 9.4 of the European Commission's CTR questions and answers. In multi-country trials, these sections may need to be varied per member state, as the age of legal competence and national rules on assent can differ across jurisdictions.

Section 5 addresses situations where consent must be witnessed by an impartial witness, referencing indirectly article 29 of the CTR and the applicable good clinical practice standard (ICH E6(R3), the internationally recognised guideline on the conduct of clinical trials) on consent witnessing procedures. 

Section 6 governs emergency enrolment under article 34 CTR: it requires a justification of why prior consent cannot be obtained, a description of how consent will be sought from the participant or a legal representative as soon as possible after enrolment, and, where a representative initially consented, the procedure for re-consenting the participant if they subsequently regain capacity. Each of these four sections also contains a national-requirement field, reflecting that domestic rules on legal representatives, emergency enrolment conditions and related matters vary considerably across member states.

Transition and timing

The updated template version was published on EudraLex volume 10 in January this year, at which point the European Commission recommended its use for all new Part II submissions. A formal transition period runs until 1 September. Retrospective implementation does not appear to be required: sponsors with trials already authorised, or with Part II applications currently under review at the date of publication, are not expected to adopt the new template. For sponsors planning new multinational trials with a target submission in the second half of 2026 or beyond, the new version should be treated as the operative format now.

The transition period also presents a natural opportunity 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 that did not fully reflect the level of procedural granularity now expected. The direction of travel is consistent with a broader regulatory trend: the permanent clinical trial flexibility framework proposed by the European Medicines Agency similarly reflects regulators' growing interest in detailed procedural disclosure around remote and digital consent arrangements, albeit in a different context. 

Osborne Clarke comment

The new template's architecture effectively converts chapter five of the CTR, entitled "Protection of subjects and informed consent", into a structured disclosure exercise that should be completed and justified per member state. That shift in framing carries potential consequences beyond compliance mechanics: 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 – a dynamic that sits within the broader overhaul of EU pharmaceutical legislation currently reshaping the sector's regulatory environment.

For pharma and biotech sponsors managing multi-country trials, 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. CROs and investigator sites to whom responsibility for completing template sections is delegated may find it useful to verify, ahead of submission, that the level of procedural detail reflected in the template aligns with actual site-level practices, particularly for the vulnerable population sections where documentation expectations are at their most granular.

The template is explicitly described as mandatory for all clinical trials, and the care with which it is completed is likely to be a tangible factor in any CTR application dossier. Its value depends ultimately on the accuracy and specificity of the information entered in each field for each trial and jurisdiction. The template itself is explicit that national language requirements and member state-specific rules must be taken into account throughout.