Trials run inside your Canadian hospital.
How ZINOS fits Health Canada's trial rules and the provincial laws that protect health information.
Trial approval in Canada.
A drug trial may start if Health Canada raises no objection within 30 days and the ethics board approves.SourceFood and Drug Regulations, C.05.005 and C.05.006, laws-lois.justice.gc.ca (current to 21 June 2026)Food and Drug Regulations, C.05.010
- Protocol and application
- Health Canada, 30 daysSourceFood and Drug Regulations, C.05.005 and C.05.006, laws-lois.justice.gc.ca (current to 21 June 2026)
- Research ethics board approvalSourceFood and Drug Regulations, C.05.010
- Device ITA, Class II–IVSourceHealth Canada, ITA applications guidance, modified 23 October 2023
- Trial conduct
- 15-year record retentionSourceFood and Drug Regulations, C.05.012(4); SOR/2022-18
Canadian rules, and how ZINOS fits.
- ICH E6(R3), applied since April 2026: the site holds its recordsSourceHealth Canada, notice to stakeholders, 17 October 2025
- Health Canada's draft guidance expects audit trails: every change loggedSourcecanada.ca
- Provincial health information law: the record stays under your controlsSourceOffice of the Privacy Commissioner of Canada, December 2015
- Quebec: assessment before specified transfers out; records can stay on-siteSourcelegisquebec.gouv.qc.ca
- Nova Scotia: personal information stays in Canada; deploy in-provinceSourcePIIDPA, nslegislature.ca
Where the record sits in Canada.
With on-premise deployment, Health Canada and the ethics board receive what the rules require, and the record stays inside your hospital.SourceFood and Drug Regulations, C.05.010
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- Research ethics board
- Health Canada
- Sponsor
- Monitor
Canadian requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Ethics approval before a site starts | Food and Drug Regulations, C.05.010SourceFood and Drug Regulations, C.05.010 | Approval tracking in the site file |
| 15-year trial record retention | Food and Drug Regulations, C.05.012(4)SourceFood and Drug Regulations, C.05.012(4); SOR/2022-18 | Configurable retention and archival |
| Audit trail on electronic records | Health Canada draft guidance GUI-0100Sourcecanada.ca | Every change logged, time-stamped, attributed |
| Electronic signatures | Draft GUI-0100, for proposed regulationsSourcecanada.ca | Signatures built to 21 CFR Part 11 |
| Assessment before specified transfers out of QuebecSourcelegisquebec.gouv.qc.ca | Quebec health and social services information ActSourcelegisquebec.gouv.qc.ca | On-premise deployment in the province |
| Personal information stored in Canada | Nova Scotia PIIDPASourcePIIDPA, nslegislature.ca | Deployment on hospital servers |
| Each row states a design fact about ZINOS, not a compliance claim. | ||
See ZINOS against Canadian rules.
Book a call on running trials in Canada, and bring your DPO.