Run your trials inside your Czech hospital.
How ZINOS fits SÚKL review, Czech ethics committees, and national requirements for consent documents.
Trial approval in Czechia.
SÚKL and at least one ethics committee assess each application independently.SourceSÚKL, legal regulations governing clinical trials
- Protocol and dossier
- Submission through CTISSourceema.europa.eu
- SÚKL assessmentSourceSÚKL, legal regulations governing clinical trials
- Ethics committee opinionSourceSÚKL, legal regulations governing clinical trials
- Trial conduct
Czech rules, and how ZINOS fits.
- Czech consent forms; translations for foreign participants: versioned per languageSourcesukl.gov.cz
- Device investigations notified through SÚKL's system: documents trackedSourceSÚKL, clinical investigations
- Ethics approval before start: tracked in the site fileSourceSÚKL, legal regulations governing clinical trials
Where the record sits in Czechia.
With on-premise deployment, SÚKL and the ethics committee receive what the rules require, and the trial record stays inside your hospital.SourceSÚKL, legal regulations governing clinical trials
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- Ethics committee
- SÚKL
- Sponsor
- Monitor
Czech requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Ethics opinion before start | Act 378/2007, as amendedSourceSÚKL, legal regulations governing clinical trials | Approval tracking in the site file |
| Consent documents in Czech | SÚKL guideline KLH-CTIS-01Sourcesukl.gov.cz | Versioned consent documents per language |
| Device investigations | SÚKL information system, since March 2024SourceSÚKL, clinical investigations | Versioned, signed submission documents |
| 25-year trial file retention | Clinical Trials Regulation, Art. 58SourceRegulation (EU) No 536/2014, Art. 58, eur-lex.europa.eu | Configurable retention and archival |
| Each row states a design fact about ZINOS, not a compliance claim. | ||
See ZINOS against Czech rules.
Book a call on running trials in Czechia, and bring your DPO.