Health Canada opens consultation on draft guidance for decentralized clinical trials 

Health Canada has launched a public consultation on draft guidance intended to clarify how decentralized and hybrid clinical trials can be conducted within Canada’s existing regulatory framework, as part of its broader clinical trials modernization initiative. The consultation opened on December 23, 2025 and will remain open until February 21, 2026.

The draft guidance on decentralized clinical trials (DCTs) is positioned as an interim measure, providing regulatory clarity while wider reforms to Canada’s clinical trial framework are under development. It explains how DCTs are regulated under Part C, Division 5 of the Food and Drug Regulations, supported by the International Council for Harmonizations Guideline for Good Clinical Practice (ICH E6). The guidance applies to Phases 1 to 4 clinical trials involving pharmaceuticals, biologics, and radiopharmaceuticals conducted in humans, and excludes trials involving medical devices, natural health products, or foods for special dietary purposes.

Health Canada defines DCTs as studies in which “some or all trial-related activities are conducted at locations other than traditional trial centers with the help of digital health technologies and virtual methods.” According to the guidance, decentralized elements can “help reduce the travel burden for participants and also make clinical trials more accessible and diverse,” enabling researchers and healthcare providers in remote regions to contribute to pan-Canadian research without the need for physical co-location.

The guidance emphasizes that decentralization does not alter regulatory expectations. While trial activities may take place outside traditional sites, “the regulatory requirements are the same as any other clinical trial.” Sponsors must demonstrate through their clinical trial applications that decentralized elements are not against participants’ best interests, that risks are minimized and appropriately monitored, and that study objectives can be achieved.

This continuity of standards has been echoed by stakeholders reviewing the draft. Vatche Bartekian, President and Founder of Vantage BioTrials, Inc., commented:

“This draft guidance reinforces that while trial activities may be decentralized, expectations around participant safety, data integrity, ethics, and oversight remain unchanged.”

Risk-based design and oversight are central themes throughout the guidance. Health Canada states that “Sponsors must identify the decentralization-related risks and manage those risks according to the regulations and ICH E6 guidelines.” DCTs should be operationally feasible, ethically appropriate, and proportionate to participant risk, and should “avoid unnecessary burden on participants, investigators and trial-related personnel.” The guidance also highlights the importance of flexibility, allowing participants to opt in or out of decentralized elements as their needs change.

The document provides clarity on oversight arrangements for decentralized activities. Where a single qualified investigator oversees all trial activities, 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 supervision is maintained.

Practical guidance is provided across several areas of decentralized trial conduct, including:

• Trial planning and design
• Delegation and oversight of trial activities
• Use and validation of digital health technologies
• Engagement of local healthcare providers and third parties
• Informed consent in decentralized settings
• Data integrity, security, and inspection readiness

Health Canada notes that digital systems used in DCTs must be validated for their intended purpose, with safeguards for audit trails, access control, data security, and inspection access. Where activities are delegated to third parties, written agreements are expected to clearly define roles, responsibilities, and liabilities. As the guidance states:

“Agreements that are clearly written and set out the division of responsibilities can help trial personnel, service providers and local healthcare providers comply with applicable laws, regulations and professional standards.”

Informed consent and inspection readiness are also highlighted as key considerations. While virtual consent approaches may improve access, the guidance cautions against disadvantaging participants who lack access to or prefer not to use digital tools, raising issues related to equity, privacy, and data protection. Inspections will remain anchored at the main trial location, with the possibility of inspecting additional locations based on risk, including non-traditional settings such as participants’ homes.

When finalized, the guidance will represent Health Canada’s current approach to decentralized clinical trials under the existing regulatory framework, ahead of future regulatory amendments linked to the modernization initiative. Reflecting on the broader significance of the draft, Dejan Spasic, Vice President Operations at dicentra, described it as:

“A strong step toward aligning Canada with the reality that trials are increasingly hybrid, patient-centric, and globally distributed,”

adding that decentralized trials are “no longer ‘a COVID workaround’” but “the blueprint for modern, global clinical development.”