Consultation: Draft guidance on decentralized clinical trials
Current status: Open
Opened on December 23, 2025, and will close to new input on February 21, 2026.
Health Canada has drafted a guidance document on decentralized clinical trials. The draft guidance outlines regulatory considerations and practical strategies for conducting clinical trials with decentralized elements in Canada. These considerations are set out in Part C, Division 5 of the Food and Drug Regulations and supported by the International Council for Harmonization Guideline for Good Clinical Practice (ICH E6).
We’re also modernizing how clinical trials are regulated to better accommodate new trial types and designs.
Join in: how to participate
Send us an email
Send an email to bpsip-bpspiconsultation@hc-sc.gc.ca with your ideas or comments to make yourself heard.
Participate by mail
Send a letter with your ideas and input to the address provided below.
Who is the focus of this consultation
We will engage with interested parties, including:
- clinical trial sponsors and investigators
- health care providers
- industry stakeholders
- patients interested in participating in clinical trials
Key points about the draft guidance
The draft guidance explains the current regulatory requirements and other considerations for decentralized clinical trials. In decentralized trials, some or all trial-related activities take place at locations other than traditional clinical trial centres with the help of digital health technologies and virtual methods.
Decentralized elements can:
- reduce the travel burden for participants
- make clinical trials more accessible and diverse
- connect researchers and other health care providers in remote areas to pan-Canadian research efforts
The draft guidance is being published for consultation. We will develop the final version of this guidance based on public feedback.
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St.
Address Locator: 3106B
Ottawa ON K1A 0K9
Email: bpsip-bpspiconsultation@hc-sc.gc.ca