Estonia has a single ethics committee for medicinal product trials, attached to the State Agency of Medicines, and hands the data protection check for much research to ethics committees. Capture gives Estonian teams EU-hosted data capture, eConsent and an audit trail, free to try.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Estonia
Key points for studies in Estonia
Regulation
Estonia moved to a centralised model for medicinal product trials in 2022: applications go through CTIS, Ravimiamet is the competent authority, and one national Clinical Trials Ethics Committee, placed under the Agency, provides the ethical evaluation. For a sponsor this simplifies planning, because there is no choice between local committees and no need to coordinate several opinions inside Estonia.
The boundary of that committee is the point to watch. It evaluates trials of medicinal products for human use, not non-interventional observational studies. A questionnaire study, a registry project or an observational cohort goes to a research ethics committee instead, and your first task is to establish which route your design takes. Device clinical investigations are a separate regime again; see EDC for medical device clinical trials.
Estonia's Personal Data Protection Act gives ethics committees a role that many countries leave to the data protection authority. Where special-category data such as health data is processed for research without the participant's consent, committee approval is required, and the committee assesses both research ethics and data protection. Committee approval also features for biobank processing, data from the health information system and clinical trials. If no suitable ethics committee exists in the area, the Data Protection Inspectorate checks compliance. Consent-based research follows GDPR Article 9 and your own data protection impact assessment.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Consent and identity
Estonia is known for national digital identity and e-signatures, so it is worth being precise: Capture does not integrate with Estonian ID-card, Mobile-ID or Smart-ID. Instead eConsent records the participant's on-screen signature verified with a one-time email code, then the investigator's countersignature with password re-authentication. Each signature is hashed to the exact document content, and the signed PDF carries the signature data, timestamps and audit trail. Participant-facing text is whatever your approved Estonian (and, if needed, Russian) materials say; plan the translations and approvals yourself, and talk to us if the study needs more than one participant language.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Build the visit schedule and forms, run data entry with edit checks, and export the blank eCRF PDF for your committee.
Estonian research
Clinical research in Estonia is concentrated in Tartu and Tallinn, with university and regional hospitals, strong academic research groups and a nationwide biobank whose participants gave broad consent for health and genomic data to be used in approved studies. For a sponsor planning a trial, that means experienced investigators, a small country where sites can be activated in parallel, and participants who are used to digital services. Many studies are investigator-initiated or academic, where the sponsor duties are the same as for industry but the budget is not.
Capture removes the cost barriers that usually decide that question: no setup fee, no per-site fee, a free sandbox with every feature, and payment only when the study goes live. Because the AI study builder reads a protocol (PDF, DOCX or DOC) and drafts the visit schedule and forms for human review, an academic team can reach a testable draft quickly. See EDC for investigator-initiated trials.
Estonian sites often join regional studies with their Baltic neighbours. In an EU trial that is one CTIS application with national assessments of each country's part, and one study database with site-level access. Read the regional overview in clinical trial software for the Baltics and the neighbouring guide to Lithuania.
At a glance
| Study type | Ethics body | Data system focus |
|---|---|---|
| Medicinal product trial (EU CTR) | Clinical Trials Ethics Committee, via CTIS | Locked forms, audit trail, signed consent, SDTM export |
| Non-interventional or observational study | A research ethics committee | Lean eCRFs, ePRO diaries, coded IDs |
| Health data research without consent | Ethics committee also assesses data protection | Pseudonymised views, exportable audit trail |
| Device clinical investigation | Applicable device and ethics route | Device and incident forms |
General summary, not legal advice. Confirm the route with Ravimiamet or the relevant committee.
Before you start
CTR trial or non-interventional study, and therefore which ethics committee.
For medicinal product trials, with national documents in the languages required.
Consent or an Article 9 research condition, with committee approval where the Act requires it.
Estonian, and Russian if participants need it.
Forms, edit checks and consent tested with sample data before go-live.
Site coordinator, researcher and admin roles set, training recorded.
The State Agency of Medicines (Ravimiamet) is the competent authority. Medicinal product trials are applied for in CTIS under the EU Clinical Trials Regulation.
For medicinal product trials, a single Clinical Trials Ethics Committee subordinated to the State Agency of Medicines. Non-interventional studies go to a research ethics committee, such as those at the University of Tartu or the National Institute for Health Development.
Under the Personal Data Protection Act, ethics committees assess data protection standards when special-category data is processed for research without consent. The Data Protection Inspectorate checks compliance where no suitable committee exists.
No. Consent signatures are verified with an email one-time code and the investigator countersigns with password re-authentication. There is no national e-identity integration.
In the EU (Frankfurt), chosen at study setup. Capture does not host inside Estonia.
Yes. One study can hold sites in Estonia, Latvia and Lithuania, with site-level access and by-site exports.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
EU-hosted EDC, eCRF and eConsent for Estonian studies. Free sandbox, no credit card.