Closed consultation: Draft guidance on decentralized clinical trials
Current status: Closed
This consultation ran from December 23, 2025 to February 21, 2026.
Health Canada has published a draft guidance document on decentralized clinical trials. This document describes the current regulatory considerations and practical strategies for conducting clinical trials with decentralized elements in Canada.
Who was the focus of this consultation
The Government of Canada engaged with interested parties, including:
- clinical trial sponsors and investigators
- health care providers
- industry stakeholders
What we heard
To view the summary report of the consultation, see What we heard: Draft guidance on decentralized clinical trials.
Key points for discussion
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
Health Canada has published a draft guidance to describe the current regulatory requirements and other considerations for decentralized clinical trials, as they are currently set out in the Food and Drug Regulations (Part C, Division 5).
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St, Holland Cross - Tower B
Address Locator: 3106B
Ottawa ON K1A 0K9
Email: bpsip-bpspiconsultation@hc-sc.gc.ca