Canada

Canada

Health Canada’s Clinical Trials Database

Verified on January 19, 2022

Canada does not have a clinical trial registry of its own. The health authority of Canada that is Health Canada has a Clinical Trials Database that provides a listing of information on clinical trials. Health Canada encourages the sponsor to register trials in the available public registries (ClinicalTrials.gov and ISRCTN).

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
Health Canada’s Clinical Trials Database Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-3)
English
French
Canadian Cancer Trials Academic/Patient Registries/Voluntary Patient organization Clinical Trial Application Not Applicable (NA) English
French
ClinicalTrials.gov Country requiring/recommending ClinicalTrials.gov use Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 2-4)
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
Health Canada’s Clinical Trials Database Registration

Yes

Prior to the initiation of the trial
Results

n/a

NA
Canadian Cancer Trials Registration

n/a

NA
Results

n/a

NA
ClinicalTrials.gov Registration

Yes

Within 21 days of the first subject enrollment
Results

Yes

Primary Results - within one year of primary completion date (PCD); Subsequent Results - within one year of the last subject last visit for each secondary outcome measure (SOM); Final Results - within one year of the study completion date

Registry Updates


References


  1. Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications. Health Canada. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec-eng.pdf. Published May 29, 2013. Accessed February 26, 2019.