A Greek trial needs a favourable scientific assessment from EOF and a favourable ethical assessment from the National Ethics Committee, both through CTIS, with key participant documents in Greek. Capture gives Greek sponsors and hospital investigators an EU-hosted EDC, ePRO and eConsent with a clean audit trail.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Greece
Key points for studies in Greece
Regulation
In Greece a clinical trial of a medicinal product requires prior approval from EOF following an application through CTIS. EOF's documents map the Greek review items to the Part II sections of the CTIS dossier: recruitment arrangements, subject information and informed consent, suitability of the investigator, suitability of the facilities, and proof of insurance cover or indemnification. The National Ethics Committee prepares the ethical assessment report under Article 7 of the Regulation, and a positive scientific and a positive ethical assessment are both required.
Because Part II looks at the consent form, the recruitment text and the site, the data system is part of the evidence. You will want a blank eCRF PDF that shows every form and the visit-by-form matrix, a consent template with a version history, and a role model showing who at each hospital can see identifiable data. All three come out of the sandbox before a single participant is enrolled. EOF also publishes separate rules for non-interventional studies, which sit outside the Regulation under a Joint Ministerial Decision from 2025, so check which route your design follows.
Published guidance for Greece says the core participant-facing documents must be in Greek. That includes the consent form and the information sheet, so the electronic consent must carry the approved Greek text. Capture does not claim multilingual support. Tell us your language needs before the build so we can say what is practical, and use official translations for any validated questionnaire.
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 simplified map based on published guidance. Confirm the current EOF procedure and fee schedule before relying on it.
| Review item | Who looks at it | What Capture can show |
|---|---|---|
| Scientific and safety content (Part I) | EOF, with other member states concerned | Blank eCRF PDF, edit check configuration, visit schedule |
| Ethical assessment | National Ethics Committee (EEE) | Consent template, version history, assent options |
| Subject information and consent form | Part II, nationally assessed | Signed consent PDF with timestamps and audit trail |
| Investigator and facility suitability | Part II, nationally assessed | Site-level roles, delegation and training records |
| Insurance or indemnification | Part II, nationally assessed | Not a system function; document in the trial master file |
| Data protection compliance | Controller; Hellenic DPA supervises | EU hosting, pseudonymised views, audit export |
Data protection
Greek law 4624/2019 supplements GDPR and was published in the Government Gazette in August 2019. Secondary commentary notes that it permits processing for scientific research without the data subject's consent where suitable safeguards are in place, but a prospective trial normally relies on explicit consent to participate and on the controller's own lawful basis for the data. Law firm guidance for Greek clinical trials also reports that a data protection impact assessment has to be carried out and that participants must receive privacy information. Check each point with your data protection officer or Greek counsel.
The Hellenic Data Protection Authority supervises. For the data system the useful thing is to be able to describe technical measures in plain terms. Capture's EU region keeps study data in Frankfurt with AES-256 encryption at rest and TLS in transit, site coordinators see names while researchers see coded IDs, and an append-only audit trail records who changed what and why. The broader picture is in GDPR compliant clinical trial software.
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.
Greek research setting
Greek clinical research is anchored in the large university hospitals in Athens and Thessaloniki and in academic research centres, with industry trials alongside. Non-commercial sponsors need a tool with no setup fee and no per-site fee, and a way to test the full study before committing budget.
Enrolled
38 / 60
Open queries
7
Forms approved
9 / 9
Behind plan
Export the blank eCRF, draft the consent and run through a test visit. Free, with every feature.
Multinational trials
Greek hospitals regularly join multinational trials, especially in oncology, cardiology and rare diseases. In a multi-country trial the sponsor submits one CTIS application, Greece is a member state concerned, and the Greek Part II documents are assessed nationally. Keep one database for the whole study, one set of forms and checks, and attach the Greek consent version to Greek sites. See multi-site clinical trial management and the regional overview of the EU CTIS submission guide.
Safety reporting is the other cross-border workflow. Adverse event and SAE forms carry timestamps and sign-off, and the deadlines your protocol sets are tracked on the sponsor side; see adverse event reporting software. If you also work with neighbouring Balkan or Mediterranean sites, the same one-database pattern applies.
Before you start
Part I and Part II, with the Greek-language documents in place.
Electronic consent text identical to the approved Greek version.
Hosting, pseudonymisation, retention and processors documented.
Evidence filed in the trial master file, outside the EDC.
Each hospital as a site, with named users and training recorded.
EOF, the National Organization for Medicines, gives the scientific assessment and approval, and the National Ethics Committee gives the ethical assessment. Applications go through CTIS.
Published guidance says the application, protocol, participant information, consent form, labelling, patient cards and insurance contract should be in Greek, with most other documents allowed in English. Confirm with EOF.
Capture does not claim multilingual support. Discuss your language needs with us before you build so we can say what is practical.
In the EU (Frankfurt), chosen at study setup. It is inside the EU/EEA but not inside Greece.
GDPR together with Law 4624/2019, supervised by the Hellenic Data Protection Authority. Ask your data protection officer about research-specific points.
There are no setup or per-site fees. The sandbox is free with every feature, and you pay only when real participants are enrolled.
Yes. Capture suits Phase 1, 2 and 3 with audit trail, e-signatures, edit checks, queries and role-based access.
Yes, with no credit card and no time limit.
Keep exploring
EU CTR clinical trial software
The regulation in detail.
EU CTIS submission guide
Preparing the dossier.
GDPR compliant trial software
Data protection.
Clinical trial software in Romania
Another South-East European guide.
eConsent software
Signed, auditable consent.
Software for European universities
Academic sponsors.
EU-hosted EDC, ePRO and eConsent. Free sandbox, no credit card.