ACDM News Item

Guidance on Decentralized Clinical Trials to be Reviewed by the ACDM RC DMEG

Date: August 17, 2026

Health Canada (HC) continues to publish new guidelines to support their modernization of the framework for clinical trials. On August 14, 2026 HC published Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100). The guidance includes sections on records retention and management, good clinical practices and serious unexpected adverse drug reaction reporting. You can view the guidance online or download a PDF document here.

GUI-0100 applies to any party involved in the conduct of clinical trials of drugs in human participants in Canada. The guidance is meant to provide additional clarification to ICH E6, which HC adopted in April 2026. The guidance specifies that “Health Canada has recognized a need to provide guidance in the interpretation of Part C, Division 5 of the Regulations, and specifically in terms of its relationship to ICH E6. This guidance document is intended to fulfill this need, as well as to provide additional guidance where isnecessary or when ICH E6 does not apply.”

As an example, HC provides clarifications in the Interpretation section 5.010 c. Standard Operating Procedures including that there should be a mechanism to ensure approval, revision and communication of new and/or revised SOPs to those responsible for the implementing the procedure. The guidance also notes that the documentation should cover all critical study-related activities and provides examples of these including: informed consent, adverse event management and monitoring.

The ACDM DMEG Regulatory considerations will be reviewing the new guidance to determine the impact on data managers and evaluate publishing a summary of the points that impact data managers.

Thank you to the DMEG for sharing this update. Find out more about the group here

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