Serbia is not an EU member, so the EU CTIS route does not apply: sponsors file with the medicines agency ALIMS and the national Ethics Committee. Capture is a self-serve EDC hosted in Frankfurt that Serbian sites can test free before go-live.
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Study region
Serbia
Key points for studies in Serbia
Regulation
For medicines without a marketing authorisation, and for devices without a completed conformity assessment, the sources describe a government-appointed national Ethics Committee reviewing alongside ALIMS, with parallel submission. Local ethics review at the site may also apply. A multinational sponsor used to a single EU CTIS dossier should therefore plan a separate Serbian workstream, with its own forms, fees and timelines. For the EU procedure that Serbia sits outside, see the EU CTIS submission guide.
Review time is reported differently: one source says ALIMS typically approves within 60 days, others report faster in some cases. Treat these as hearsay and ask the agency.
What the filing 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, and every field change carries a timestamp, user, old and new value and reason. See audit trail software for clinical trials.
If your programme includes a Serbian Phase I site, sources report that the October 2023 amendment limited such trials to public healthcare institutions. Check whether that has changed and which site types are currently eligible before you commit to a site list.
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 |
|---|---|---|---|
| Filing | Sponsor or local representative | Protocol, IB or IMPD, consent, investigator and site details | Blank eCRF PDF of the approved forms. |
| Regulatory review | ALIMS | Quality, safety, design | Edit checks and derived fields documented in the form. |
| Ethics review | Ethics Committee of Serbia, site committee | Consent, recruitment, 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. |
| Oversight | Sponsor monitors, ALIMS inspectors | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources. Confirm national detail with ALIMS 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
Serbian trial data is personal data, and health data is sensitive. Sources describe the Serbian data protection law as modelled on the GDPR, supervised by a national commissioner. Because Serbia is outside the EU, two transfer questions arise: moving data from Serbian sites to an EU-hosted system, and EU sponsors receiving Serbian data. Neither is answered by hosting alone. Ask counsel what is needed in consent, contracts and records.
Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Frankfurt keeps storage inside the EU for a European sponsor, but Capture does not hold data in Serbia. 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 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 Serbian-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
••••••••••
Operating reality
Serbian research is concentrated around Belgrade, Novi Sad and Niš, with university clinical centres and a mix of public and private institutions. A typical pattern is a sponsor elsewhere in Europe adding Serbian sites to a regional protocol. That makes site-level participant numbering and by-site exports useful, so Serbian data can be reviewed without opening other countries.
Neighbouring and regional pages: Bulgaria, Romania, Hungary, Slovenia, Greece, Turkey and the wider Central and Eastern Europe view. For running sites across borders, read multi-site clinical trial management.
Before you start
Confirm the ALIMS and Ethics Committee submission steps and who files.
Ask counsel whether you need a local sponsor representative and a data protection representative.
Check current rules for the phase and site type, especially for Phase I.
Approved Serbian-language consent text and participant information; decide how it is delivered.
Contracts and consent wording for data moving between Serbia and the EU.
Audit trail description, role matrix and hosting region for your vendor assessment.
Per secondary sources, the Medicines and Medical Devices Agency (ALIMS) and a national Ethics Committee, with simultaneous filing. Confirm current procedures with them.
No. Serbia is not an EU member state, so the EU Clinical Trials Regulation and CTIS do not govern a Serbian application. A national filing applies.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). Capture has no Serbian data centre or office, and transfer questions are for your counsel.
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 is assessed.
Sources say foreign sponsors may need one, and possibly a separate data protection representative. Ask counsel for your situation.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to Serbian 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 Bulgaria
EU neighbour under CTIS.
Clinical trial software in Romania
Neighbouring EU market.
Clinical trial software in Hungary
Central European sites.
Clinical trial software in Turkey
Another non-EU market.
EU CTIS submission guide
The route Serbia sits outside.
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.