In 2025, Health Canada has released a draft guidance on decentralized clinical trials, now opening a public consultation that runs until February 21, 2026. This update represents a key milestone in Canada’s ongoing clinical trials modernization initiative and provides long-awaited regulatory clarity for sponsors and investigators planning decentralized or hybrid trial designs.
Regulatory Framework for Decentralized Clinical Trials
The draft guidance explains how decentralized clinical trials are regulated under Part C, Division 5 of the Food and Drug Regulations, supported by the International Council for Harmonisation Guideline for Good Clinical Practice (ICH E6). It applies to phases I to IV clinical trials involving pharmaceuticals, biologics, and radiopharmaceuticals conducted in humans in Canada.
The guidance does not apply to clinical trials involving medical devices, natural health products, or foods for special dietary purposes.
Decentralized clinical trials are defined as studies where some or all trial-related activities occur outside traditional clinical trial centres. These activities may rely on digital health technologies, virtual methods, and community-based health care resources to support trial conduct.
Key Elements of the Draft Guidance
The guidance provides practical direction across the full clinical trial lifecycle, including trial design, submission of clinical trial applications, informed consent, delegation and oversight, data integrity, and inspection readiness.
Health Canada confirms that decentralized elements may be used where they are operationally feasible, ethically appropriate, and proportionate to participant risk. However, the guidance clearly reinforces that regulatory expectations remain unchanged. Sponsors and qualified investigators retain full accountability for participant safety, Good Clinical Practice compliance, and the integrity and reliability of trial data.
The guidance also clarifies that when decentralized activities are overseen by a single qualified investigator, all locations are considered part of one clinical trial site. In these cases, additional Clinical Trial Site Information forms or separate research ethics board approvals are not required for each remote location, provided activities are conducted under the approved protocol and appropriate oversight is maintained.
Use of Digital Health Technologies and Third Parties
The draft guidance outlines expectations for the use of digital health technologies, including requirements for validation, data security, audit trails, and inspection access. It also addresses delegation of trial-related activities to local health care providers, laboratories, pharmacies, and other third parties, emphasizing the importance of clear documentation, defined responsibilities, and effective communication to protect participant safety.
Sponsors are expected to identify decentralization-related risks and implement appropriate mitigation strategies through protocol design, contracts, informed consent processes, and quality systems.
Why This Guidance Matters for Sponsors and Investigators
This draft guidance provides important regulatory certainty for decentralized and hybrid clinical trial models in Canada. It supports more participant-centric study designs that can reduce travel burden, improve access for underrepresented populations, and strengthen recruitment and retention, while maintaining strong regulatory oversight.
It also signals Health Canada’s intent to formally accommodate innovative trial designs within the existing regulatory framework, ahead of broader regulatory amendments under the clinical trials modernization initiative.
How to Submit Feedback
Stakeholders, including sponsors, investigators, contract research organizations, health care providers, and patients, are encouraged to submit comments on the draft guidance. Feedback can be provided by email to bpsip-bpspiconsultation@hc-sc.gc.ca
until February 21, 2026.
Early engagement in this consultation offers an opportunity to help shape how decentralized clinical trials will be regulated and implemented in Canada going forward.
SNI Clinical Research Support for Decentralized Clinical Trials
At SNI Clinical Research, we support sponsors at every stage of decentralized and hybrid clinical trial execution. From protocol development and risk-based trial design to CTA support, informed consent workflows, and inspection readiness, our team designs participant-centric studies that align with Part C, Division 5 of the Food and Drug Regulations and ICH E6 Good Clinical Practice.
With hands-on experience integrating decentralized elements, digital health technologies, and community-based trial activities, SNI helps sponsors operationalize innovative trial designs while maintaining regulatory compliance, data integrity, and participant safety.
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