Bulgaria applies the EU Clinical Trials Regulation, so one CTIS dossier reaches both the Bulgarian Drug Agency and the ethics committee. Capture is a self-serve EDC hosted in Frankfurt that Bulgarian sites can test free before go-live.
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Study region
Bulgaria
Key points for studies in Bulgaria
Regulation
Under the EU regulation a sponsor files one application in CTIS covering all concerned member states. The reporting member state validates it and leads the assessment of Part I (the scientific and quality content); each concerned state, including Bulgaria if it is one, assesses Part II (national items such as consent, site suitability and compensation). In Bulgaria the sources describe the BDA and the Central Ethics Committee at the Ministry of Health dividing that work under an ordinance on how they coordinate. For the EU procedure itself, read our EU CTIS submission guide and EU CTR clinical trial software.
What the dossier needs from a data system is a clear description of what is collected and how it is protected. Capture produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which supports the protocol and Part II package. Regulators and ethics committees also expect an inspectable record: every field change in Capture carries a timestamp, the user, the old and new value and the reason, and the trail cannot be edited through the interface. See audit trail software for clinical trials.
A Bulgarian consultancy reports that the BDA and the ethics committee announced shorter review periods, with evaluation possibly finishing within 35 days of validation for some mono-national, single-centre, later-phase trials. A different guide says the BDA typically reviews within 60 days. The two may describe different trial types. Treat both as hearsay and confirm with the agency.
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.
Who does what
| Step | Who | What is needed | Where Capture helps |
|---|---|---|---|
| Dossier submission | Sponsor or legal representative in the EU | Protocol, IB or IMPD, consent, site and investigator details | Blank eCRF PDF of the approved forms. |
| Scientific assessment (Part I) | Reporting state, with BDA input where Bulgaria concerned | Design, safety, endpoints | Edit checks and derived fields documented in the form. |
| National items (Part II) | BDA and the Central Ethics Committee | Consent, recruitment, site suitability, data protection | eConsent record with countersignature and signed PDF. |
| Site start-up | Hospital or clinic, principal investigator | Agreement, delegation, training | Site accounts, roles and site-level participant numbering. |
| Ongoing oversight | Sponsor monitors, BDA inspectors | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources and the regulation. Confirm national detail with the BDA and the ethics committee.
Build the visit schedule, forms and checks free, hand the blank eCRF PDF to your regulatory lead, and pay only when real participants enrol.
Data protection
Bulgarian trial data is personal data under the GDPR, and health data is a special category. The national data protection authority supervises, and your sponsor and sites each have roles as controllers or processors depending on the contract. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For a Bulgarian-site study the Frankfurt region keeps storage inside the EU, which simplifies the transfer analysis. Whether any access from outside the EU (for example, a CRO or monitor based in a third country) creates a transfer is a question for your data protection officer.
In Capture, site coordinators see participant names while researchers see coded IDs, and row-level security enforces that at the database. Data is encrypted with AES-256 at rest and TLS in transit. Read GDPR compliant clinical trial software for what a processor agreement for an EDC should cover.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Capture eConsent takes the participant on-screen signature, confirmed by a one-time email code, then the investigator countersigns with password re-authentication. Witness and legally authorised representative signatures are supported, each signature is hashed to the exact document content, and the signed PDF carries the timestamps and audit trail. The consent wording is yours. Language support is not claimed here, so if your Bulgarian-language materials must be delivered inside the platform, ask us what is currently available before you plan around it.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Research landscape
Bulgaria is usually a contributor to multinational studies run from elsewhere in Europe, with university hospitals in Sofia, Plovdiv, Varna and Pleven and a mix of public and private clinics. A common pattern is a sponsor in another country adding Bulgarian sites to a CTIS trial for recruitment speed. That makes site-level participant numbering and by-site exports useful, so Bulgarian data can be reviewed and reconciled without opening other countries.
Neighbouring regions have their own pages: Romania, Hungary, Slovenia and the wider Central and Eastern Europe view. For running sites across borders, read multi-site clinical trial management.
Before you start
Confirm which state is reporting member state and that Bulgaria is a concerned state in the dossier.
Get the BDA review expectation in writing instead of using blog figures.
Approved Bulgarian-language consent text and participant information; decide how it is delivered.
Processor agreement, records of processing, transfer analysis for any non-EU access.
Who reports SUSARs, to which system, within which timelines per the regulation.
Audit trail description, role matrix and hosting region for your vendor assessment.
Medicinal product trials run under EU Regulation 536/2014. Secondary sources name the Bulgarian Drug Agency and the Central Ethics Committee at the Ministry of Health as the national bodies. Confirm current procedures with them.
For medicinal product trials under the EU regulation, yes. Sources report submission through CTIS became mandatory from 31 January 2023, with ongoing trials transitioned by 31 January 2025. Device and non-interventional studies follow different rules.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). For a Bulgarian study the Frankfurt region keeps data in the EU. Capture has no Bulgarian data centre or office.
No regulator approves EDC software in that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what an inspector looks at.
Sources disagree: a 35-day route is reported for some single-country later-phase trials and about 60 days elsewhere. Ask the BDA, and plan from the regulation's own timelines for multinational dossiers.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to Bulgarian-language ePRO or consent screens.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in Slovenia
JAZMP, KME and CTIS.
Clinical trial software in Romania
Neighbouring EU market.
Clinical trial software in Hungary
Central European sites.
EU CTIS submission guide
How the EU portal works.
GDPR compliant clinical trial software
Processor and hosting questions.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF before any fee. You pay only when real participants enrol.