CEE countries are in the same EU framework but each runs its own Part II ethics review, language rules and hospital start-up. Capture gives a CEE programme one EU-hosted study, identical forms at every site and a free sandbox to test it first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Central and Eastern Europe
Key points for studies in Central and Eastern Europe
Regulation
Since the EU Clinical Trials Regulation replaced the old directive, a sponsor files one CTIS dossier and picks a reporting member state. Part I, the scientific and safety content, is assessed jointly. Part II is national: each country decides on informed consent materials, recruitment, compensation, data protection arrangements and whether sites and investigators are suitable. That is why a trial in Warsaw, Prague and Budapest can reach go-live on three different days.
National practice differs in detail. Poland has required CTIS since 1 January 2023 and its authority issues the final decision on the basis of the bioethics committee opinion, with published fees that depend on the trial type. In the Czech Republic the authority designates a multicentric ethics committee, and fees for the Part II assessment are handled after designation. Non-interventional studies there commonly follow a lighter notification regime. For Hungary, Romania and others, check the national medicines agency and ethics body directly, because routes and fee rules change. Our wider explainer on the regulation is at EU CTR clinical trial software.
Because each country can request changes to consent or participant information, you may end up with country-specific consent versions inside one protocol. Keep the form set for each version controlled and the active version visible. In Capture, forms move from draft to approved, approved forms are locked for live use and consent signatures are linked to the exact document at signing. See eConsent software for clinical trials.
Pre-launch readiness
1 site activated
1 form not yet approved
The CEE ecosystem
CEE countries are commonly included in multinational programmes because they combine university hospitals, experienced investigators and large treatment populations at competitive site costs. Oncology, cardiology, immunology and vaccine studies are frequent, and so are investigator-initiated and academic trials funded nationally or through EU grants.
Start-up planning matters more than data capture. Contract templates, hospital administration, local-language document sets and drug import logistics usually set the pace. A study database that is ready before sites are approved lets you train staff and rehearse visits in the meantime. Capture has no per-site fee and a free sandbox with every feature, so you can build all forms and test edit checks before the first site is greenlit. Details on running several countries in one study are in multi-site clinical trial management.
Multi-country control
Participants are numbered by site, site coordinators work in their own portal and only see their own participants, and sponsor-side users can filter and export by site. Edit checks raise an auto-query as soon as a value breaks a rule, so a sparsely staffed hospital gets the same data quality gate as a large centre.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Build the forms, set the roles and run a mock visit in the free sandbox. No credit card, no time limit.
At a glance
A starting map, not an authority. Confirm each row with the national agency and the ethics body before you plan around it.
| Country | Authority / route | What to plan |
|---|---|---|
| Poland | URPL decision, bioethics committee opinion, CTIS | Published fees by trial type; Polish consent and participant information |
| Czech Republic | SÚKL designates a multicentric ethics committee in CTIS | Fee handling for Part II after designation; lighter route for non-interventional studies |
| Hungary | National medicines agency and ethics body (check current names and route) | Hungarian-language Part II documents; confirm with the agency |
| Romania | National medicines agency and ethics bodies (check current names and route) | Romanian-language documents; confirm with the agency |
| Other CEE EU members | CTIS with national Part II | Local-language materials and hospital contracts |
General practice summary, not legal advice. Hungary and Romania rows were not verified in detail.
Before you start
Decide who leads Part I and which countries are member states concerned.
Consent, participant information and recruitment texts approved per country.
GDPR basis, any national research rule, pseudonymisation and hosting described in your DPIA.
Hospital administration timelines tracked per site.
Export the blank eCRF PDF with form index and visit-by-form matrix.
Site coordinator, researcher and admin roles assigned per site.
Yes. One study holds sites in many countries with site-level access, site-level participant numbering and exports filtered by site.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Most EU studies use Frankfurt. If your institution requires in-country storage, check that before you start.
Under the EU CTR each member state assesses Part II nationally, and the exact body differs by country. In Poland the decision rests on a bioethics committee opinion; in the Czech Republic a multicentric committee is designated. Confirm the current route with the national agency.
Participant-facing documents are normally needed in the local language. Participant text in Capture is whatever your approved materials say; talk to us if you need to understand how your study will handle several languages.
Yes. See the Baltics page, plus the Latvia, Estonia and Lithuania guides, which cover the regional setup in detail.
Yes. The sandbox has every feature, with no credit card and no time limit. You pay only once real participants are enrolled.
Keep exploring
Clinical trial software for the Baltics
The northern neighbours.
EU CTR clinical trial software
CTIS and Part I / Part II.
Multi-site clinical trial management
Sites across countries.
GDPR compliant trial software
EU data protection.
Clinical trial software for the DACH region
Germany, Austria, Switzerland.
Clinical trial software in Germany
The western neighbour.
EU-hosted EDC, eCRF and eConsent. Free sandbox, no credit card.