Run your trials inside your Dutch hospital.
How ZINOS fits CCMO and MREC review, the NEN 7510 security standard, and Dutch rules on research data.
Trial approval in the Netherlands.
The CCMO validates each application and assigns one committee, which assesses both parts of the dossier.SourceCCMO, National Clinical Trial OfficeCCMO, Full or staggered application
- Protocol and dossier
- Submission through CTISSourceema.europa.eu
- CCMO validationSourceCCMO, National Clinical Trial Office
- One committee, both partsSourceCCMO, Full or staggered application
- Trial conduct
Dutch rules, and how ZINOS fits.
- NEN 7510, 7512, and 7513: access logged, records securedSourceStaatsblad 2017, 446
- Electronic consent permitted since July 2022: eICF with signaturesSourceCCMO, Toestemming: op papier of elektronisch
- Research exemption under the UAVG: pseudonymisation configurableSourceUAVG, Art. 24, wetten.overheid.nl
Where the record sits in the Netherlands.
With on-premise deployment, the CCMO and the committee receive what the rules require, and the trial record stays inside your hospital.SourceCCMO, National Clinical Trial OfficeCCMO, Full or staggered application
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- MREC
- CCMO
- Sponsor
- Monitor
Dutch requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Information security in healthcare | NEN 7510, 7512, 7513SourceStaatsblad 2017, 446 | Audit trail and access logging |
| Electronic consent | CCMO and NVMETC guidance, 2022SourceCCMO, Toestemming: op papier of elektronisch | Tablet eICF with audit trail |
| Research use of health data | UAVG, Art. 24SourceUAVG, Art. 24, wetten.overheid.nl | Configurable pseudonymisation, logged access |
| 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 Dutch rules.
Book a call on running trials in the Netherlands, and bring your DPO.