Hungary is a long-established clinical research country where one central ethics committee, ETT-KFEB, and the pharmacy institute OGYÉI work through CTIS. Capture gives Hungarian sponsors and investigators an EU-hosted EDC, ePRO and eConsent that produces the files both bodies ask for.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Hungary
Key points for studies in Hungary
Regulation
All clinical trials of medicinal products in Hungary are regulated by OGYÉI, which approves applications through CTIS where Hungary is the reporting member state and takes part in coordinated assessment where it is a member state concerned. The ETT-KFEB, the Clinical Pharmacology Ethics Committee of the Health Science Council, gives the ethics statement. A university document lists both as pre-start requirements: the OGYÉI licence and the ETT-KFEB professional statement.
Third-party country profiles describe the Part I and Part II assessments running in parallel, with different figures for the national phase across sources, so treat any timeline you read online, including this page, as indicative. The ETT site notes that when Part I and Part II are submitted together, all listed Part II documents must be provided. Your data system supports that mainly by producing consistent artefacts: the blank eCRF PDF, the consent template and the role and training records.
ETT-KFEB provides a Hungarian-language list of Part II documents to help the lay members of the committee evaluate a submission. For a sponsor that is a reminder that consent text is read by non-specialists: keep participant-facing wording short and consistent, and make sure the electronic consent in the system is the version that was reviewed. See what is informed consent and eConsent software.
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.
At a glance
A practical map, not a legal checklist. The authorities publish the authoritative lists.
| Document or record | Who asks for it | Where it comes from in Capture |
|---|---|---|
| Protocol and schedule of assessments | OGYÉI and ETT-KFEB | Visit schedule built or AI-drafted from the protocol, then approved |
| Blank eCRFs | OGYÉI and ethics committee | Blank eCRF PDF export with form index and visit matrix |
| Participant information and consent form | ETT-KFEB (Part II) | Consent template with versions and signed PDF export |
| Investigator and site suitability | ETT-KFEB (Part II) | Site setup, role assignment and training acknowledgements |
| Data protection documentation | Controller, NAIH supervises | EU hosting, role-based access, exportable audit trail |
| Safety reports | Sponsor and OGYÉI | Adverse event and SAE forms with timestamped sign-off |
Data protection
Hungarian trials sit under GDPR and the national health data act, Act XLVII of 1997, with NAIH as the supervisory authority. From the beginning of 2026 amendments to that act created a controlled way for authorised applicants to use anonymised datasets from the national eHealth infrastructure (EESZT) for purposes such as AI training and device development, inside a secure processing environment. NAIH has publicly questioned how truly anonymous such data can be. This is a national data reuse programme, not something your trial database needs to connect to, but it is a good reason to keep your own export and sharing plan explicit.
For trial data, the practical questions are standard and worth recording in the data management plan: who is controller, which processors touch the data, where the data is hosted, who can see identifiable fields and how long records are kept. Capture covers the technical side with Frankfurt hosting, AES-256 at rest and TLS in transit, coded IDs for researchers, names only for site coordinators, and an append-only audit trail. See GDPR compliant clinical trial software and clinical trial data archiving and retention.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Data quality
Hungarian sites are experienced and often sponsor-monitored. A system that raises auto-queries when a value breaks a range or custom rule, keeps a field-level audit trail with reason for change, and lets monitors mark source data verification per field fits that style of working.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Draft forms from your protocol, configure checks and queries, and export the blank eCRF. Free, no credit card.
Research landscape
Hungary has a long record of participating in industry trials, with strong university centres in Budapest, Debrecen, Szeged and Pécs, and an active investigator-initiated sector in oncology, cardiology and neurology. In a multi-country trial Hungary is one member state concerned in the same CTIS application as Poland, Czechia, Romania or Austria, and the Hungarian Part II is assessed nationally. Keep one database, one set of forms and country-specific consent versions per site. The multi-site workflow is covered in multi-site clinical trial management, and the German-speaking neighbour is in clinical trial software Germany.
Academic sponsors can start without a contract. There is no setup fee or per-site fee, and the sandbox contains the full feature set; payment begins only when you enrol real participants. For university groups the same applies as elsewhere in Europe; see clinical trial software for European universities. Language is the one point to settle first: Capture does not claim multilingual support, so share your Hungarian-language needs before the build.
Before you start
CTIS application with Part I and Part II complete.
Electronic consent matches the version the committee reviewed.
Controller, processors, hosting region, access and retention in the data management plan.
One site per hospital, roles assigned, training recorded.
Edit checks run on realistic sandbox data.
Who completes and signs adverse event forms, with timing in the protocol.
OGYÉI, the National Institute of Pharmacy and Nutrition, is the regulator, and the ETT-KFEB ethics committee gives the ethics statement. Applications run through CTIS. Check the official sites for current names.
The Clinical Pharmacology Ethics Committee of the Hungarian Health Science Council, described in country profiles as the ethics body in the CTIS review.
GDPR applies, together with the national Act XLVII of 1997 on health-related personal data. NAIH supervises. Ask your data protection officer about research specifics.
No. It hosts in the EU (Frankfurt) or the USA. Frankfurt is inside the EU/EEA but not inside Hungary.
Capture does not claim multilingual support. Tell us your language needs before building so we can say what is practical.
Yes. One study can hold sites in several countries with site-level access and by-site exports.
Yes. Capture suits Phase 1, 2 and 3.
Yes. The free sandbox has every feature, no credit card and no time limit.
Keep exploring
EU CTR clinical trial software
The regulation in detail.
GDPR compliant trial software
Data protection.
Clinical trial software Germany
A neighbouring EU guide.
Clinical trial software in Romania
Another Central and Eastern European guide.
Audit trail software
What inspectors read.
What is an IRB or ethics committee?
Ethics review explained.
EU-hosted EDC, ePRO and eConsent. Free sandbox, no credit card.