Health Canada publishes guidance on clinical trials with decentralized elements: Notice
October 27, 2026
Our reference number: 26-106084-898
On this page
- Background
- About clinical trials with decentralized elements
- Consultation process
- What changed in the guidance
- What's next
- Contact us
Background
Health Canada has published new guidance on clinical trials with decentralized elements. The guidance explains how existing regulatory requirements under Part C, Division 5 of the Food and Drug Regulations apply when decentralized elements are used in the design and conduct of a clinical trial.
Guidance for clinical trials with decentralized elements
About clinical trials with decentralized elements
Clinical trials with decentralized elements incorporate activities that occur partially or entirely away from traditional clinical trial sites.
Decentralized elements may include:
- remote visits
- home-based trial activities,
- electronic informed consent processes
- technologies used to collect remote data
- involvement of local health care providers
- shipping of investigational products closer to participants
These approaches may improve access for participants by reducing geographic and logistical barriers. They also provide greater flexibility in how trials are conducted.
While decentralized elements can offer significant benefits, the conduct of the trial remains subject to the same requirements for participant protection, data integrity and regulatory compliance. Trial sponsors and investigators are responsible for ensuring participant safety, protecting trial data and maintaining compliance with applicable regulatory requirements.
Consultation process
We released a draft of this guidance on December 23, 2025, and accepted public feedback until February 21, 2026. We received 35 submissions from a broad range of interested parties, such as:
- sponsors
- investigators
- technology providers
- academic researchers
- research ethics boards
- patient advocacy groups
- health care professionals
- contract research organizations
Read a summary of the feedback.
What changed in the guidance
We used the feedback we received to make the guidance clearer and better organized.
We also strengthened the content dealing with regulatory and organizational matters, such as:
- using digital technologies
- preparing for a Health Canada inspection
- handling a drug product across multiple sites
- equity, accessibility and participant-centred design
- adding decentralized elements once a trial has been approved
- expectations for risk-proportionate quality management, including critical-to-quality factors
- roles, responsibilities and oversight of sponsors, qualified investigators, delegated personnel and service providers
What’s next
We will update the guidance again to reflect the new regulations once the modernized regulatory framework for clinical trials comes into force. We expect to publish the final version of the regulations in the Canada Gazette, Part II, in spring 2027. This will be followed by a coming-into-force period of 1 year.
Modernizing the framework for clinical trials
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada