Run your trials inside your Polish hospital.
How ZINOS fits the 2023 clinical trials act, URPL and bioethics review, and Polish medical record rules.
Trial approval in Poland.
URPL authorises the trial; the Supreme Bioethics Committee and listed committees give the ethics opinion.SourceABM, 20 April 2023
- Protocol and dossier
- Submission through CTISSourceema.europa.eu
- URPL assessmentSourceABM, 20 April 2023
- Bioethics committee opinionSourceABM, 20 April 2023
- Trial conduct
Polish rules, and how ZINOS fits.
- Medical records kept 20 years: configurable retention and archivalSourcePatient Rights Ombudsman, gov.pl
- Device investigations: bioethics opinion, then URPL permitSourceURPL, Badania kliniczne wyrobów medycznych
- Clinical Trials Support Centres: one system across studiesSourceABM, competition 2024/ABM/4/KPO results, 19 December 2024
Where the record sits in Poland.
With on-premise deployment, URPL and the bioethics committee receive what the rules require, and the trial record stays inside your hospital.SourceABM, 20 April 2023
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- Bioethics committee
- URPL
- Sponsor
- Monitor
Polish requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Ethics opinion before start | Act of 9 March 2023SourceABM, 20 April 2023 | Approval tracking in the site file |
| Medical record retention | Act on Patient RightsSourcePatient Rights Ombudsman, gov.pl | Configurable retention and archival |
| Device investigations | Bioethics opinion and URPL permitSourceURPL, Badania kliniczne wyrobów medycznych | 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 Polish rules.
Book a call on running trials in Poland, and bring your DPO.