A Canadian drug trial combines a Health Canada clinical trial application with research ethics board approval at each site, under federal and provincial privacy laws. Capture gives Canadian sponsors and investigators an EDC, ePRO and eConsent with an audit trail, hosted in the EU (Frankfurt) or the USA (N. Virginia).
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Canada
Key points for studies in Canada
Regulation
Health Canada's framework for clinical trials is built on Part C, Division 5 of the Food and Drug Regulations, in force since 2001. A CTA is required for trials of unapproved products and for marketed products used outside their authorised parameters, and the same 30-day logic applies to amendments. There is no fee to submit a CTA. If the application is deficient, Health Canada tells the sponsor; if it is acceptable, a No Objection Letter is issued within the review period. A draft guidance has proposed formal authorisation letters and longer review times for some applications, so verify whether that has taken effect before you plan timelines.
Ethics runs in parallel. Each participating site needs approval from its research ethics board, working to the Tri-Council Policy Statement (TCPS 2). Several Canadian institutions state that final REB approval is not granted until the NOL arrives, so keep the NOL in the submission tracker. For certain higher-risk device studies the sequence differs, with REB approval first. In Ontario, PHIPA specifies that only one REB approval is required for a research project, which is why multi-site networks use shared review.
For the CTA and the REB, Capture exports a blank eCRF PDF with cover page, form index and visit-by-form matrix, and holds a version-controlled consent template. For inspection, it keeps a field-level, append-only audit trail with user, timestamp, old value, new value and reason for change, plus electronic signatures with re-authentication. Canadian GCP expectations follow ICH; see what is GCP and the 21 CFR Part 11 compliance checklist, which many sponsors use as a benchmark for electronic records.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
At a glance
Canada has no single national health privacy law, so the answer depends on province, sponsor type and data flow. This is a simplified map, not legal advice.
| Question | Typical source | What to record in Capture |
|---|---|---|
| Can the trial start? | Health Canada CTA, then NOL | Blank eCRF, visit schedule, audit trail design |
| Is the participant protected? | Institutional REB under TCPS 2 | Consent versions and signed PDFs per site |
| Commercial personal data handling | PIPEDA | Roles, access controls, retention |
| Ontario custodians' health information | PHIPA | Site-level separation of identifiable data |
| Quebec participants | Law 25 and Quebec health information act | Privacy impact assessment for transfers outside Quebec |
| Cross-border data | Institution and province policy | Hosting region recorded and justified |
Privacy
Because Canada's privacy regime is layered, a national study may satisfy different rules at different sites. Sources on Quebec note that Law 25 requires a privacy impact assessment when personal information is transferred outside Quebec and when evaluating research use without consent, and that the 2023 act on health and social services information is modelled on PHIPA but adds Law 25-inspired requirements, with entry into force set by decree. The in-force status of the health act should be checked with Quebec counsel. None of this is a hosting mandate, but it is a reason to document your choice of region.
Capture's two regions are the EU (Frankfurt) and the USA (N. Virginia), chosen at study setup. Neither is in Canada, and Capture does not claim in-country storage. Whether offshore hosting is acceptable is a decision for your REB, your institution's privacy office and, for public bodies, any provincial rule. The technical measures you can cite are AES-256 encryption at rest, TLS in transit, coded IDs for researchers and sponsors, names visible only to site coordinators, and row-level security. See EU-US data privacy framework for clinical research and GDPR compliant clinical trial software for the transfer logic.
Canadian consent materials often need approved French versions, especially for Quebec sites. Capture does not claim multilingual support, so tell us your language needs before you build and we can say what is practical.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Multi-site studies
Canadian academic and network trials often run across provinces, each with its own REB and privacy context. Capture gives each hospital its own site, a separate site coordinator portal, site-level participant numbering and by-site filtering and exports, so each province's data can be separated for local reporting while the sponsor sees one dataset.
Enrolled
84 / 120
Open queries
12
REB approvals
4 of 5
French consent pending
Set up sites, test the consent flow and export a blank eCRF for your REB. Free, no credit card.
Research setting
Canadian clinical research is anchored in academic health science centres, provincial networks and a biotech sector clustered around Toronto, Montreal and Vancouver, and Canada is a frequent country in global Phase 2 and 3 programmes. Investigator-initiated trials are common and often grant-funded, which suits a platform with no setup or per-site fees. See EDC for investigator-initiated trials and clinical trial software for universities.
In a global trial, Canada is one regulatory arm alongside the FDA and, for European sites, the EU CTR. Keep one database with country-specific consent versions per site, and use ePRO for patient-reported outcomes, decentralized clinical trial software and eConsent where the protocol supports remote participation. Wearable data can sync by native OAuth; Oura is the device named on the site.
Before you start
Health Canada application and any amendments, with the NOL stored in the trial master file.
Consent versions identical to each REB-approved text.
PIPEDA, PHIPA, Quebec rules and institutional policy for each province.
EU (Frankfurt) or USA (N. Virginia), documented for the REB and privacy office.
Delegation, signatures and training acknowledgements recorded.
See SAE reporting timelines and data archiving.
Health Canada, under Part C, Division 5 of the Food and Drug Regulations. Sponsors file a Clinical Trial Application and receive a No Objection Letter when it is acceptable.
The standard period is 30 days, and the same applies to amendments. Draft guidance has proposed longer periods for some applications, so check current guidance.
Yes. Each participating institution needs research ethics board approval before a trial is initiated, and many REBs wait for the NOL before final approval.
PIPEDA federally, provincial health laws such as Ontario's PHIPA, and Quebec's Law 25 and health information act. Confirm which apply with your privacy office.
Not with Capture. It hosts in the EU (Frankfurt) or the USA (N. Virginia). Check REB, institution and provincial policy on storing health data outside Canada.
Capture does not claim multilingual support. Tell us your language needs before building.
Yes. Capture suits Phase 1, 2 and 3.
Yes. The free sandbox has every feature, no credit card and no time limit.
Keep exploring
21 CFR Part 11 compliance checklist
A benchmark for electronic records.
Clinical trial software UK
Another Commonwealth regime.
Clinical trial software New Zealand
Medsafe and HDEC.
EU-US data privacy framework
Cross-border transfers.
Multi-site trial management
Many sites, one study.
What is an IRB or ethics committee?
Ethics review explained.
EDC, ePRO and eConsent with an audit trail. Free sandbox, no credit card.