Run your trials inside your UK hospital.
How ZINOS fits the 2026 clinical trials regulations, HRA approval, and NHS data security rules.
Trial approval in the United Kingdom.
Since April 2026, the MHRA and a research ethics committee review each trial together, applied for through IRAS.Sourcelegislation.gov.uk/uksi/2025/538; HRA, 28 April 2026HRA, HRA Approval
- Protocol and IRAS applicationSourceHRA, HRA Approval
- Combined MHRA-ethics reviewSourcelegislation.gov.uk/uksi/2025/538; HRA, 28 April 2026
- HRA approval, NHS sitesSourceHRA, HRA Approval
- Trial conduct
- Results within 12 monthsSourceMHRA, archiving and retention of clinical trial records, 28 April 2026; GOV.UK, 27 April 2026
UK rules, and how ZINOS fits.
- Trial files kept 25 years: configurable retention and archivalSourceMHRA, archiving and retention of clinical trial records, 28 April 2026; GOV.UK, 27 April 2026
- NHS data: Data Security and Protection Toolkit; records stay insideSourceNHS England Digital, 21 May 2026
- NHS hosting: UK, EEA, or adequate countries; your hospital decidesSourceNHS England Digital, off-shoring and public cloud guidance, updated 7 February 2023
- National data opt-out: consented trial data outside its scopeSourceNHS England Digital, Understanding the national data opt-out
Where the record sits in the UK.
With on-premise deployment, the MHRA and the ethics committee receive what the rules require, and the trial record stays inside your hospital.Sourcelegislation.gov.uk/uksi/2025/538; HRA, 28 April 2026HRA, HRA Approval
- 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
- MHRA
- Sponsor
- Monitor
UK requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Combined review before start | Clinical trials regulations, SI 2025/538Sourcelegislation.gov.uk/uksi/2025/538; HRA, 28 April 2026 | Approval tracking in the site file |
| Security of NHS patient data | Data Security and Protection ToolkitSourceNHS England Digital, 21 May 2026 | On-premise deployment in your hospital |
| Where NHS data may be hosted | NHS off-shoring guidanceSourceNHS England Digital, off-shoring and public cloud guidance, updated 7 February 2023 | Hospital-controlled deployment |
| 25-year trial file retention | Clinical trials regulations, reg. 31ASourceMHRA, archiving and retention of clinical trial records, 28 April 2026; GOV.UK, 27 April 2026 | Configurable retention and archival |
| Each row states a design fact about ZINOS, not a compliance claim. | ||
See ZINOS against UK rules.
Book a call on running trials in the United Kingdom, and bring your DPO.