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Guidance Document

publicHealth Canada · Canada · Updated Aug 14, 2026

Health Canada Guidance on Clinical Trials Involving Human Subjects (GUI-0100)

Urgency: High

Clinical safety and pharmacovigilance teams must ensure that their SUADR reporting processes are aligned with the new 7-day and 15-day notification timelines, and maintain robust systems for collecting safety data from international sites.

ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Guidance Document
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