In Slovenia JAZMP does the scientific review and the national Medical Ethics Committee (KME) the ethics review, both inside the EU CTIS process. Capture is a self-serve EDC hosted in Frankfurt for small and academic Slovenian teams.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Slovenia
Key points for studies in Slovenia
Regulation
Since Regulation 536/2014 started to apply, medicinal product trials are applied for in CTIS. JAZMP's clinical trial pages explain the old national route and the new one, and the Official Gazette decree on implementing the regulation assigns the roles above. Fees are set separately for the agency and the ethics committee, and reduced for categories such as non-commercial or paediatric trials, according to the fee schedule we found; check the current schedule before you budget.
Studies outside the regulation (device studies, many non-interventional studies, academic questionnaires) follow other national routes, and the ethics committee remains central. If you are unsure which route fits, ask JAZMP and KME early. For the EU mechanics, see our EU CTIS submission guide and EU CTR clinical trial software.
Both reviewers want to understand how data is collected and protected. Capture exports a blank eCRF PDF showing every approved form empty, and keeps a field-level audit trail with timestamp, user, old value, new value and reason for change.
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.
Assessment split
| Part | Typical content | Slovenian body (as read) | Where Capture helps |
|---|---|---|---|
| Part I | Scientific rationale, design, safety, product quality | JAZMP | Edit checks, derived fields and safety forms documented in the form. |
| Part II | Consent, recruitment, site suitability, compensation, data protection | KME RS | eConsent record, signed PDF, role-based access. |
| Transparency | Registration and result summaries | Sponsor via CTIS | SDTM export for results datasets. |
| Oversight | Inspection of sites and records | Authority inspectors | Audit trail, queries, SDV by field. |
Allocation is taken from a secondary reading of the implementing decree. Confirm with JAZMP and KME.
Create a demo study, assign site and researcher roles and export the blank eCRF PDF, all free.
Data protection
Health data is a special category under the GDPR, and research is allowed with a lawful basis, safeguards and, in many cases, participant consent. The national Information Commissioner supervises compliance, and Slovenian institutions have data protection officers who will ask about processors, hosting and international access. Frankfurt hosting keeps data in the EU. If a CRO or monitor outside the EU can view it, treat that as a transfer to analyse.
In Capture, site coordinators see participant names while researchers see coded IDs, enforced at the database by row-level security. AES-256 protects data at rest and TLS in transit. Compare approaches in GDPR compliant clinical trial software.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Participants sign on-screen and confirm with a one-time email code. The investigator then countersigns with password re-authentication, and optional witness and legally authorised representative signatures are supported. Each signature is hashed to the exact document, and the signed PDF includes timestamps and audit trail. Slovenian-language screens are not claimed here, so ask about current language support before planning a Slovenian-language consent flow inside the platform. Whether KME accepts electronic consent for your design is for the committee to say.
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
Slovenian research is concentrated in Ljubljana and Maribor, around the University Medical Centres and the medical faculties, with strong activity in cardiology, oncology and rare disease networks. The country is a handy partner in regional trials with neighbours, and a natural pairing with Bulgaria, Hungary and Romania.
When Slovenian sites are one arm of a wider study, site-level participant numbering and by-site exports keep data separate, as described in multi-site clinical trial management. For academic teams, EDC for academic clinical trials covers the typical set-up.
Before you start
CTIS for medicinal product trials; national route for other study types.
Current JAZMP and KME fee schedules, including reductions that may apply.
Approved Slovenian text; decide how it is delivered to participants.
Processor agreement, DPIA where needed, transfer analysis.
Audit trail description, role matrix, hosting region (Frankfurt).
For medicinal products under the EU regulation, JAZMP handles scientific review and validation and the Slovenian Medical Ethics Committee (KME RS) handles ethics review, according to the implementing decree we found. Confirm with both.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For Slovenian studies Frankfurt keeps data in the EU. There is no Slovenian data centre.
No regulator approves EDC software this way. Capture gives you an audit trail, e-signatures and access controls, and your validated use is assessed.
No. Capture is self-serve with no office, partner or CRO in Slovenia.
This page does not claim multilingual support. Ask us about current language options before committing.
A Slovenian fee schedule we found halves some fees for non-commercial, paediatric and orphan product trials. Check the current schedule with JAZMP and KME.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only when you go live.
Keep exploring
Clinical trial software in Bulgaria
EU CTR in a neighbouring region.
Clinical trial software in Hungary
Central European sites.
Clinical trial software in Germany
Frankfurt-hosted EU data.
EU CTIS submission guide
How CTIS works.
EDC for academic clinical trials
University set-up.
Pricing
Free sandbox, pay at go-live.
Build, test and export the blank eCRF PDF in the free sandbox. Pay only when real participants enrol.