Run your trials inside your Austrian hospital.
How ZINOS fits BASG review, Austria's ethics committee platform, and Austrian rules on health data.
Trial approval in Austria.
For national trials, BASG aims to decide within 35 days, with an ethics committee from the national platform.SourceBASG, Klinische Prüfungen von Arzneimitteln, 9 July 2025Parliament, explanatory notes 1289 d.B.; AustrianEthics
- Protocol and dossier
- Submission through CTISSourceema.europa.eu
- BASG assessmentSourceBASG, Klinische Prüfungen von Arzneimitteln, 9 July 2025
- Ethics committee platformSourceParliament, explanatory notes 1289 d.B.; AustrianEthics
- Trial conduct
Austrian rules, and how ZINOS fits.
- Consent documents in German, on the national template: versionedSourceBASG, Nationale Anforderungen, 24 May 2024
- ELGA health data stored within the EU: on-premise deploymentSourceHealth Telematics Act 2012, s. 20
- Broad consent for research areas: consent scope recordedSourceFederal Chancellery, FOG s. 2d(3)
Where the record sits in Austria.
With on-premise deployment, BASG and the ethics committee receive what the rules require, and the trial record stays inside your hospital.SourceBASG, Klinische Prüfungen von Arzneimitteln, 9 July 2025Parliament, explanatory notes 1289 d.B.; AustrianEthics
- 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
- BASG
- Sponsor
- Monitor
Austrian requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Ethics opinion before start | Ethics committee platform, Medicines ActSourceParliament, explanatory notes 1289 d.B.; AustrianEthics | Approval tracking in the site file |
| ELGA data storage | Health Telematics Act 2012, s. 20SourceHealth Telematics Act 2012, s. 20 | On-premise deployment in your hospital |
| Broad research consent | Research Organisation Act, s. 2d(3)SourceFederal Chancellery, FOG s. 2d(3) | Consent scope recorded per participant |
| 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 Austrian rules.
Book a call on running trials in Austria, and bring your DPO.