New Health Canada Guidance and Important Implications for CIHR-Funded Trials

Health Canada has released new Guidance on the Registration of Clinical Trials and Public Disclosure of Results, effective July 29, 2026.

The guidance establishes policy expectations for sponsors of Health Canada-regulated clinical trials, including Phase I–III drug and natural health product trials and investigational testing of Class II–IV medical devices.

What are the Expectations?

Sponsors are expected to:

• Register applicable trials in a registry that meets World Health Organization standards, ideally before enrolment and no later than 21 calendar days after the first participant is enrolled.
• Keep the registry record accurate and current.
• Submit structured summary results to the same registry within 12 months following the trial’s Primary Completion Date.

Health Canada will also use information from international registries to populate its new Canadian Clinical Trial Search Portal.

What Does This Mean for University of Alberta Investigators?

For University of Alberta-sponsored trials, Qualified Investigators and study teams should work with the Clinical Trials Office (CTO) to ensure that sponsor responsibilities for registration, registry maintenance, and results disclosure are met.

For industry-sponsored trials, these activities will generally remain the industry sponsor’s responsibility.

There are particularly important implications for CIHR-funded clinical trials.

For clinical trial grants funded on or after January 1, 2022, CIHR requires investigators to:

• Have summary results publicly available within 12 months of the Primary Completion Date.
• Make publications open access from the date of publication.
• Include the trial registration number in publications.

Compliance with these requirements is necessary to remain eligible for new CIHR funding.

Primary Completion Date is Not Necessarily Study Completion Date

The Primary Completion Date is the date on which the final participant globally was examined or received the intervention for the purpose of final data collection for the primary outcome measure or measures.

It is not necessarily the date on which all secondary outcomes, safety follow-up or other study activities are completed.

For example, if a primary outcome is measured at Week 12 but safety follow-up continues through Week 52, the 12-month results-disclosure clock begins when the final participant completes the Week 12 primary-outcome assessment—not when the overall study ends.

What Should Investigators Do?

Investigators and study teams, particularly those involved in CIHR-funded clinical trials, should:

• Verify that the trial is registered and the record is current.
• Record the Primary Completion Date separately from the overall Study Completion Date.
• Calculate the results-disclosure deadline from the Primary Completion Date.
• Confirm who is responsible for preparing and posting registry results.
• Contact the CTO early enough to allow for registry review before the deadline.

Read the Full CTO Implementation Guide Below

Key Resources

• Health Canada guidance*
• WHO Joint Statement on Public Disclosure of Results from Clinical Trials
• CIHR Policy Guide on Registering and Disclosing Clinical Trial Results

*The Health Canada guidance currently describes strongly advised policy expectations rather than requirements established in law. CIHR’s applicable funding-policy requirements are already in effect.

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