Canada

Canada

Health Canada’s Clinical Trials Database

Verified on December 1, 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


  • March 2022: Canada update - The article “Pharma is still burying clinical trial results in Canada, new study warns” has been published on March 23, 2022, on TranspariMED. According to the Canadian research team, Canada lacks regulatory requirements as some pharma companies continue to prevent clinical trial results from being made public. Trials that showed harm or safety concerns were … Continue reading "March 2022: Canada update"
  • February 2022: Canada Update - As a part of the regulatory modernization process, Health Canada had published a consultation paper in May 2021. Health Canada gathered feedback from stakeholders on the consultation paper through an online questionnaire, email submissions, and interactive webinars. Overall, 122 written submissions and close to 1000 stakeholders participated in webinars. The respondents agreed with the proposals … Continue reading "February 2022: Canada Update"
  • February 2022: Canada Update - Canadian Institutes of Health Research (CIHR) shared their policy guide on the requirements for the registration and disclosure of results from clinical trials on February 08, 2022. The policy focuses on the registration of clinical trials and making them publicly available, free to access before the first visit of the first participant. The following new … Continue reading "February 2022: Canada Update"

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.