Czech medicine trials run under the EU Clinical Trials Regulation with SÚKL and an ethics committee, and consent material must be in Czech. Capture is a self-serve EDC hosted in Frankfurt that Czech sites can test free before go-live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Czech Republic
Key points for studies in the Czech Republic
Regulation
Under the EU regulation a sponsor files one application in CTIS covering every concerned member state. Part I (the scientific and quality content) is assessed jointly; Part II (consent, recruitment, site suitability, compensation) is assessed nationally. For the Czech Republic the national dossier rules sit in SÚKL guideline KLH-CTIS-01, whose second version is dated 15 May 2023 and lists the documents that go with Part II. Read our EU CTIS submission guide and EU CTR clinical trial software for the EU procedure.
A data system feeds that dossier in two places. The protocol and Part II package describe what is collected, and Capture exports a blank eCRF PDF with cover page, form index, visit-by-form matrix and every approved form printed empty. Inspectors later look at what happened to the data, and every field change in Capture carries a timestamp, the user, the old and new value and the reason, in a trail that cannot be edited through the interface. See audit trail software for clinical trials.
If the Czech-language rule applies to your study, the approved consent text has to be Czech and the English original is not what is assessed. That is a document control problem more than a software one: keep one approved Czech version, one version number and one effective date, and make sure what participants sign matches what the committee approved. Capture eConsent records the signature against the exact document content, but it does not claim Czech-language interface screens, so ask us what is available before you plan a fully Czech-facing participant experience.
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 EU legal representative | Protocol, IB or IMPD, consent, site and investigator details | Blank eCRF PDF of the approved forms. |
| Scientific assessment (Part I) | Reporting member state, SÚKL if concerned | Design, safety, endpoints | Edit checks and derived fields visible in the forms. |
| National items (Part II) | SÚKL and the ethics committee | Czech consent, recruitment, site suitability, insurance | eConsent record with countersignature and signed PDF. |
| Site start-up | Hospital, principal investigator | Agreement, delegation log, training | Site accounts, roles and site-level participant numbering. |
| Ongoing oversight | Sponsor monitors, SÚKL inspectors | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Summarised from SÚKL pages and a law-firm overview. Confirm detail with SÚKL and the ethics committee.
Build the visit schedule and forms in the sandbox, hand the blank eCRF PDF to your regulatory lead, and pay only when real participants enrol.
Data protection
Czech trial data is personal data under the GDPR and health data is a special category. The national supervisor is the Office for Personal Data Protection (ÚOOÚ), and sponsor and sites hold controller or processor roles depending on the contract. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For a Czech study the Frankfurt region keeps storage in the EU. Whether remote access by a monitor or CRO outside the EU is a transfer is a question for your data protection officer.
In Capture, site coordinators see participant names while researchers see coded IDs, enforced by row-level security at the database. Data is encrypted with AES-256 at rest and TLS in transit. Read GDPR compliant clinical trial software for what an EDC processor agreement should cover.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
The participant signs on screen, confirms with a one-time email code and acknowledges the legal-binding statement. The investigator then countersigns with password re-authentication, and witness or legally authorised representative signatures are supported. Each signature is hashed to the document content at signing, and the signed PDF carries timestamps and the audit trail for the investigator site file.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Typical start-up
A sketch, not a regulatory timeline.
Confirm Czech trial status in CTIS and which ethics committee, local or multicentric, will review.
Get the Czech version approved and version controlled before you build the consent in the platform.
Build forms and checks in the sandbox and have Czech site staff try data entry.
Include it with the supporting detail on what is collected.
Create site accounts as each site completes start-up.
Research landscape
The Czech Republic is a regular contributor to multinational studies run from elsewhere in Europe, with university hospitals in Prague, Brno, Olomouc and Plzeň. That makes site-level participant numbering and by-site exports useful, so Czech data can be reviewed on its own before it is pooled. For running sites across borders read multi-site clinical trial management.
Neighbouring pages cover Germany, Austria, Hungary, Slovenia and the Central and Eastern Europe overview.
Medicinal product trials run under EU Regulation 536/2014, with SÚKL as the medicines authority and an ethics committee for participant protection. Confirm current procedure with SÚKL.
A 2023 SÚKL guideline on Part II documents says patient information and consent must be in Czech and that bilingual versions are not accepted. Check the current guideline for your study.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Frankfurt keeps Czech study data in the EU. There is no Czech 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 reviews.
This page does not claim multilingual interface or participant screens. Ask us about current language support before designing a Czech-facing ePRO or consent flow.
A law-firm overview reports a lighter notification-plus-ethics route. Confirm with SÚKL and your ethics committee which applies.
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 Germany
Neighbouring EU market.
Clinical trial software in Austria
BASG and ethics committees.
Central and Eastern Europe
Regional view.
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.