Romania implements the EU Clinical Trials Regulation through Emergency Ordinance 29/2022, with ANMDMR as competent authority and the national bioethics commission providing ethical opinions. Capture gives Romanian sponsors and sites an EU-hosted EDC, ePRO and eConsent with an audit trail.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Romania
Key points for studies in Romania
Regulation
Romania moved to CTIS when the system became operational on 31 January 2022, and the ordinance adopted in the same period put the national rules in place. The competent authority for interventional trials is ANMDMR. Ethical review is done by CNBMDM, which issues opinions under the Regulation. Order 3390/2022 then sets out who coordinates what: ANMDMR coordinates the national analysis of the dossier a sponsor submits through CTIS, including both assessment reports and responses to requests for information, and the two bodies exchange material over a secure electronic channel.
For a sponsor or an academic group, the practical meaning is that the national review is a joint exercise. Your consent form, participant information and recruitment material are evaluated alongside the scientific dossier. The data system supports the submission by producing a blank eCRF PDF, a version-controlled consent template and site and role records, and later by providing an audit trail that can answer an inspector's question about any value.
The two instruments above are recent, and procedures change as the CTIS ecosystem matures. Read the current ANMDMR guidance pages for fees, timelines and language requirements, and check with Romanian counsel before you rely on any summary, including this page. Device investigations follow the EU Medical Device Regulation; see EU MDR clinical investigation guide.
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 view based on the published ordinance and order. It is not a complete list of requirements.
| Body or instrument | Role | What your data system should be able to show |
|---|---|---|
| ANMDMR | Competent authority; coordinates national CTIS dossier analysis | Blank eCRF, visit schedule, edit check design |
| CNBMDM | Independent ethical review and opinion | Consent versions, assent options, signed consent PDFs |
| OUG 29/2022 | National implementation of the Regulation | Records consistent with the approved protocol |
| Order 3390/2022 | Allocates national coordination and communication | Complete, consistent Part I and Part II documents |
| Data protection authority | Supervises GDPR compliance | EU hosting, pseudonymised views, audit export |
| Sponsor and monitors | Oversee conduct and data quality | Queries, per-field SDV, field-level audit trail |
Data protection
Romania applies GDPR with a national implementing act and a national supervisory authority. As in every member state, health data is a special category, so the sponsor or institution as controller documents the lawful basis, runs a data protection impact assessment where required, and tells participants what is processed, by whom and for how long. These are controller obligations; software supplies the technical measures but does not discharge them.
Capture's EU region keeps study data in Frankfurt with AES-256 encryption at rest and TLS in transit. Site coordinators see participant names, researchers and sponsors see coded IDs, and row-level security enforces the split at the database layer. The append-only, hash-chained audit trail records user, timestamp, old value, new value and reason for every change. See GDPR compliant clinical trial software and audit trail software for clinical trials.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Multi-site studies
Romanian studies often combine several county and university hospitals. Capture gives each hospital its own site with a site coordinator portal, QR-code enrolment that needs no app install, site-level participant numbering and by-site data filtering and exports, so a monitor sees one hospital at a time and the sponsor sees all of them.
| Assessment | Screening | Week 0 | Week 4 | Week 12 |
|---|---|---|---|---|
| Consent | ||||
| Vital signs | ||||
| Adverse events | ||||
| Symptom diary | D | D | D |
x = completed at visit, D = diary
Set up sites, enrol a test participant by QR code and review the audit trail. Free, with every feature.
Research landscape
Romania is regularly included in multinational trials for its large patient population and its experienced hospital sites in Bucharest, Cluj-Napoca, Iași and Timișoara. In those studies the sponsor files one CTIS application, Romania assesses its national aspects, and the data system should hold the whole study as one database with country-specific consent versions attached to Romanian sites. For Balkan and Black Sea neighbours the same pattern applies; see clinical trial software in Greece and clinical trial software in Hungary.
Investigator-initiated studies at universities and institutes have the same obligations but smaller budgets. Capture has no setup fee and no per-site fee, and the sandbox lets a team build and test everything first. See EDC for investigator-initiated trials. Language is the point to settle early: Capture does not claim multilingual support, so describe your Romanian-language needs before building.
Before you start
Dossier prepared for ANMDMR and CNBMDM, with Part I and Part II complete.
Electronic consent matches the version reviewed.
Aligned with what the system actually does.
Each hospital as a site, with delegated staff and training.
Exports reviewed in the sandbox for inspection use.
ANMDMR is the competent authority for interventional trials, under Emergency Ordinance 29/2022. Applications run through CTIS.
The National Bioethics Commission for Medicines and Medical Devices (CNBMDM), which issues ethical opinions under the Regulation.
It assigns ANMDMR national coordination of the dossier analysis and sets up secure electronic communication with the ethics commission.
No. It hosts in the EU (Frankfurt) or the USA. Frankfurt is inside the EU/EEA, not inside Romania.
Capture does not claim multilingual support. Discuss your language needs with us before building.
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.
EU CTIS submission guide
Preparing the dossier.
Clinical trial software in Hungary
A regional neighbour.
Clinical trial software in Greece
Another South-East European guide.
GDPR compliant trial software
Data protection.
Query management software
Edit checks and queries.
EDC, ePRO and eConsent with an audit trail. Free sandbox, no credit card.