CTIS Clinical Trial Submission in Estonia

Who reviews an Estonia application

The State Agency of Medicines performs the Member State functions under the Clinical Trials Regulation. It assesses the application in cooperation with experts and the Ethics Committee for Medicinal Products. The ethics committee prepares the Part II ethical assessment and the Agency takes that conclusion into account in the national decision.

Estonia uses a single Ethics Committee for Medicinal Products for clinical trials of medicinal products. This avoids choosing between local ethics committees for different sites.

Main Estonia-specific preparation points

Mandatory. The application dossier is generally submitted in English. Information specified in Part L of Annex I to the Clinical Trials Regulation and other information aimed at participants must be in Estonian. The European Commission language table also lists Estonian for translated patient-facing documents.

Mandatory. All recruitment and participant-facing materials must carry the EU CT number. Estonia's ethics guidance also asks sponsors to use the word "participant" rather than "patient" throughout participant materials.

Recommended. Estonia publishes a national Subject Information and Informed Consent Form template approved by the Ethics Committee for Medicinal Products. The ethics committee also accepts the European Commission Part II templates.

Mandatory. For each site, the Principal Investigator CV must be in English, dated and signed, no more than six months old, and include the most recent Good Clinical Practice training information. A declaration of interests is also submitted.

Mandatory. The site suitability form uses the site's legal name and must be signed by a person legally authorised by the study centre. Estonia accepts manual or digital signatures. If the original is an Estonian .asice digital-signature container, upload a PDF in CTIS and retain the original .asice at the site.

Country-specific CTIS placement. Ravimiamet states that from 27 April 2026 Estonian-language patient-facing materials are submitted in Section R of Part II instead of Section D of Part I, except for mononational trials. English patient-facing materials for multinational trials remain in Part I as required by the EU Q&A. Treat this as an operational upload rule alongside the underlying Part II subject-information category.

The Estonia Part II document checklist maps the complete national document set and upload logic.

Estonia CTIS guide directory

Estonia CTIS Part II Document Checklist

Use this first to identify the Part II documents, signatures, templates and Estonia-specific submission details that apply.

Estonia Patient Information and Consent Requirements

Use this for the default adult Participant Information Sheet and Informed Consent Form, including Estonian language, signatures, compensation, privacy and remote consent.

Estonia Patient-Facing Document QC Checklist

Use this before submission to check protocol consistency, consent logic, EU CT numbers, privacy, samples, versions and Estonia-specific content.

Estonia Healthy Volunteer Consent Requirements

Use this when healthy volunteers are enrolled and the PIS/ICF must address volunteer-specific risks, procedures and Estonia's compensation rules.

Estonia Minor Consent and Assent Requirements

Use this for children and adolescents, including Estonia's specific 7 to 17-year consent rule and legal-representative requirements.

Estonia Limited-Capacity and Legal Representative Consent Requirements

Use this when an adult participant cannot provide valid informed consent and a legal representative is involved.

Estonia Emergency Enrollment Consent Requirements

Use this for trials proposing enrollment before prior consent under the narrow emergency conditions in Article 35 of the Clinical Trials Regulation.

Estonia Impartial Witness Consent Requirements

Use this when the participant or legal representative cannot write and an impartial witness procedure is needed.

Estonia Pregnancy Follow-Up Consent Requirements

Use this for pregnancy follow-up involving a trial participant or a participant's pregnant partner.

Estonia Secondary Use Consent Requirements

Use this when trial data or biological samples may be retained or used for optional future scientific research outside the main protocol.

Which guide should you start with

Start with the Part II document checklist if you are building the whole Estonia dossier. Use the main patient information and consent guide when drafting the default adult PIS/ICF.

Then add only the population variations your protocol actually needs. A trial involving minors, incapacitated adults, emergency enrollment, healthy volunteers, pregnancy follow-up, an impartial witness process or optional future research needs additional consent logic rather than a copy of the standard adult form.

The Estonia patient-facing document QC checklist is the final cross-document review before upload.