What we heard: Draft guidance on decentralized clinical trials
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Introduction
Health Canada published the Draft guidance on Decentralized Clinical Trials on December 23, 2025, with a public consultation held until February 21, 2026. This report summarizes the feedback received during this consultation.
Decentralized clinical trials (DCTs) rely on conducting visits and activities outside traditional trial centres, bringing research closer to participants. They can:
- improve access to clinical trials and potentially promising therapies for people across Canada, and enable community-based health care professionals and remote providers to participate in pan-Canadian research
- increase the diversity of participants in trials by connecting rural and remote communities to research led from urban centres, and supporting retention for trials that struggle to enroll sufficiently large, geographically and culturally diverse participant groups (for example, rare disease trials)
Planning and conducting a DCT may involve additional operational considerations, but regulatory requirements remain the same as for other clinical trials.
Through this consultation, Health Canada heard a range of perspectives on how to refine the draft guidance and support responsible, practical adoption of decentralized elements.
Stakeholder engagement
Health Canada invited feedback from a broad range of stakeholders, including pharmaceutical manufacturers, clinical trial sponsors, academic institutions, health care organizations, patient advocacy groups, and third-party service providers. Notifications were posted on Health Canada's health-related consultations page and distributed through mailing lists. We received 35 submissions with responses on the draft guidance from 5 respondent categories:
- Clinical trials organizations, research networks and technical experts: 12 submissions
- Health care institutions, academic medical research institutions and research ethics boards: 7 submissions
- Industry associations and pharmaceutical companies: 9 submissions
- Patient advocacy organizations: 5 submissions
- Professional associations: 2 submissions
Key themes
Most stakeholders strongly supported the draft guidance and the broader adoption of decentralized models, and some identified barriers within the current regulatory framework that could limit use of DCTs. We grouped comments into five key themes:
- International alignment of terminology and digital technology standards
- Risk-proportionate, flexible regulatory pathways
- Operational feasibility, administrative burden and practical implementation
- Roles, delegation, oversight and inspection boundaries
- Participant-centred approaches: Equity, consent and digital access
Summary of feedback
Theme 1: International alignment of terminology and digital technology standards
Stakeholders recommended adopting internationally-aligned language (for example, "clinical trials with decentralized elements").
Some stakeholders requested close harmonization with expectations from the International Council for Harmonisation (ICH), U.S. Food and Drug Agency, and the European Medicines Agency guidance, often related to Canadian participation in international trials.
Digital health technologies and software as a medical device
Industry and technical experts requested explicit guidance on when software or electronic patient-reported outcomes devices qualify as software as a medical device and when a medical device investigational testing authorization is required. Stakeholders requested Health Canada to adopt risk-based validation of computerized systems aligned with ICH E6 and to avoid open-ended validation language that exceeds global norms.
Theme 2: Risk-proportionate, flexible regulatory pathways
Tiered, risk- based approach: Several stakeholders expressed the need for clarification on documentation requirements related to risk management, and expressed support for developing a tiered framework that distinguishes low-risk decentralized elements from higher-risk activities. Further guidance was requested on proportionate documentation, monitoring, and validation expectations for computerized systems for each tier.
Clinical trial application content and operational flexibility
Stakeholders requested clarity on what to include in the clinical trial application (CTA) versus what may be provided in operational documents (monitoring plans, site supervision plans, standard operating procedures). Several stakeholders requested a model whereby CTAs contain high-level descriptions, and specific operational details are maintained in sponsor/site records.
Patient-driven decentralization
Stakeholders stressed that decentralization is often patient-driven and layered, introduced after a trial receives a "no objection letter", to meet urgent clinical needs. They asked Health Canada to permit site supervision plans and standard operating procedures in lieu of immediate CTA amendments for low-risk, post-approval decentralization and to avoid re-justifying core trial objectives for routine changes.
Theme 3: Operational feasibility, administrative burden and practical implementation
Operational feasibility and administrative burden: Feedback received regarding operational feasibility and administrative burden represented a mix of views. Practical concerns raised with regards to the draft guidance included:
- the time and cost of executing many local contracts
- long retention requirements for third-party agreements
- logistics for investigational product shipping and returns and
- the burden of collecting qualification/training records for numerous local providers
Some stakeholders requested template agreements, minimum-content checklists, and proportionate retention rules.
On the other hand, several stakeholders emphasized the importance of explicitly specifying training requirements for non-primary trial personnel, such as local healthcare providers and mobile staff, to ensure competency and data integrity in decentralized settings. Others requested additional and more detailed guidance on storage, transport conditions, and chain-of-custody documentation for investigational products delivered outside traditional sites, especially temperature-sensitive products.
Data interoperability and privacy
Stakeholders emphasized the importance of and requested strengthened guidance on electronic medical records (EMR) interoperability, vendor oversight, data residency, cybersecurity, and a Canada-specific checklist for cross-jurisdictional data flows and vendor contracts. Concerns were raised about variability in data collection methods (such as, wearables versus clinic measurements) and the complexity introduced by multiple digital platforms, highlighting the need for robust mitigation plans including training and cybersecurity safeguards.
Theme 4: Roles, delegation, oversight and inspection boundaries
Delegation and responsibilities
Respondents asked for clearer delineation of sponsor and qualified investigator responsibilities, and more explicit guidance on which activities require delegation logs as opposed to those considered routine clinical care. They requested explicit recognition of hub-and-spoke and satellite models and practical delegation examples.
Inspections and home-based activities
Many stakeholders were concerned by wording that could be interpreted to allow inspectors to enter participant homes. They asked Health Canada to limit home inspections to clearly defined hazardous circumstances, require coordination through the qualified investigator, and provide suggested consent wording that explains the low likelihood and narrow scope of home inspections.
Theme 5: Participant-centred approaches: equity, consent & digital access
Consent options and digital access
Stakeholders emphasized the need for flexible consent options (electronic, video, documented oral) while protecting participants who lack digital access. Feedback highlighted risks of digital exclusion and recommended we include additional guidance on privacy protections, secure data transmission, plain-language consent templates, identity verification examples, and requirements for sponsors to assess and mitigate digital equity barriers.
Next steps
Health Canada thanks all participants for their contributions. We will carefully consider the feedback received as we revise and finalize the guidance. Once the modernized regulatory framework for clinical trials comes into force, we will update this guidance to reflect the new regulations. In the interim, the draft guidance will remain available on our website as a reference outlining current regulatory expectations for decentralized clinical trials.