Estonia CTIS Patient Information and Consent Requirements

Use the Estonia ICF template as the national baseline

Recommended. The State Agency of Medicines and the Ethics Committee for Medicinal Products publish a Subject Information and Informed Consent Form template approved by the ethics committee. An English and Estonian version are available through the Agency's clinical-trial forms page.

The ethics committee also accepts the European Commission Part II templates. In August 2026, the Commission's revised Informed Consent and Patient Recruitment Procedure template version 2.0 is highly recommended for new Part II submissions, with the transition period ending on 1 September 2026.

The national template is a drafting baseline, not a substitute for protocol-specific content. Adapt the information to the actual intervention, procedures, population, risks, data flows, samples, reimbursement and optional research.

Language and participant-facing versions

Mandatory. Estonian law states that Part L information and other information aimed at participants must be given in Estonian. The European Commission's current country table likewise lists Estonian for translated patient-facing documents.

If participants will receive materials in another language, provide that language version as well. Ravimiamet states that all materials provided to participants must be supplied in all languages in which they are intended to be used.

For multinational trials, Ravimiamet's current CTIS instruction states that from 27 April 2026 Estonian-language patient-facing materials are uploaded in Section R of Part II. English patient-facing materials remain in Part I under the EU Q&A. For a mononational trial, follow the mononational language and placement rules in the current EU Q&A and confirm the CTIS structure before filing.

What the participant information should cover

The information should be proportionate to the trial and clear enough for a prospective participant to make a decision. For a typical medicinal-product trial, cover:

• the purpose of the research and why the person is being invited
• the investigational treatment and any comparator or randomisation
• visits, tests, procedures, samples and participant responsibilities
• foreseeable risks, burdens and inconveniences
• expected benefits, including when direct benefit is not expected
• treatment alternatives when relevant
• pregnancy, contraception and reproductive precautions when relevant
• what happens to biological samples
• how personal and health data are collected, accessed, transferred, retained and protected
• insurance or indemnification and treatment of trial-related injury
• reimbursement and any approved compensation
• voluntary participation, withdrawal and what happens after withdrawal
• contacts for study questions, safety concerns and participant rights
• any optional future research or secondary use as a separate decision where applicable

The exact content should match the protocol, other Part I documents and the Estonia Part II forms. The Estonia patient-facing QC checklist provides a cross-document review.

Consent and signature logic

Mandatory when consent is obtained. Under Article 29 of Regulation (EU) No 536/2014, informed consent is written, dated and signed by the person conducting the consent interview and by the participant or, when the participant cannot consent, the legally designated representative.

The participant or representative must receive a copy of the consent record and have adequate time to consider participation.

Estonian law adds that before consent, the participant or legal representative must speak with a trial-team member who is a doctor, nurse or pharmacist, has thorough knowledge of the trial and investigational medicinal product, and can give a complete explanation.

Estonia permits digital signatures when the signature method is valid under Estonian law.

The blank ICF submitted with the CTIS application is not signed by future participants at submission. The consent signatures are obtained when the individual is enrolled.

Remote consent in Estonia

Conditional. Ravimiamet states that remote consent may be considered when the process uses a video call and electronic identification.

The process must allow clear identification of the people involved, normal questioning and discussion, time to decide, and the same rights and opportunities that would be available in a face-to-face consent discussion.

The remote-consent procedure must be justified and approved by the Ethics Committee for Medicinal Products before implementation. A legally accepted signature is still required.

Compensation and reimbursement wording

Mandatory when reimbursement or compensation applies. Participation should not create direct unavoidable costs for the participant. Estonia requires reimbursement of unavoidable expenses caused directly by trial participation, subject to the national principles.

The application must justify the reimbursable expenses and the ICF must explain the reimbursement principles.

Estonia permits competent participants to receive justified compensation for inconvenience and burdensome procedures. The amount should reflect time and contribution and the ethics committee must approve the justification. Do not use completion bonuses or structures that pressure participants to remain in the trial.

Compensation information belongs in the ICF rather than recruitment advertising.

Different restrictions apply to minors, incapacitated participants and certain other groups. Use the relevant population guide instead of copying the standard adult wording.

Data protection and biological samples

Mandatory. Estonia requires the ICF to explain data-protection aspects in detail. The sponsor also submits the EU statement of compliance with Regulation (EU) 2016/679.

Ravimiamet recommends separate consent choices in the information form for trial participation and for the use of health data or biological samples in pseudonymised form.

Do not present the ethical informed consent required for trial participation as automatically being the General Data Protection Regulation legal basis for every data-processing operation. The European Commission and European Data Protection Board distinguish the two concepts.

If samples are collected, describe what is collected, whether it is pseudonymised or anonymised, transport, storage location, retention period and destruction. Optional research beyond the main protocol should be clearly separated. See the Estonia secondary use consent guide.

Population variations

The default adult PIS/ICF is not enough for every population.

• Healthy volunteers need volunteer-specific risk and compensation wording.
• Minors require age-appropriate information and Estonia-specific consent logic for ages 7 to 17.
• Limited-capacity participants require legal-representative and participant-involvement logic.
• Emergency enrollment is permitted only under the narrow Article 35 conditions.
• Impartial witness consent applies when the participant or representative cannot write.
• Pregnancy follow-up may require separate information and permissions.
• Secondary use should remain distinguishable from core trial participation.

Return to the Estonia CTIS hub for the complete country guide set.