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

Explore More News

Newsletter Committee: Meet Marta

The ACDM is delighted to welcome Marta Kowalska of CluePoints to the Newsletter . . .

AI model trained on de-identified data from 57 million people

Researchers at UCL have trained an AI model using de-identified data from 57 million . . .

ACDM Regulatory Considerations DMEG Update: ICH E6 (R3) GCP Final Publication Released

The final publication of ICH E6 (R3) Good Clinical Practice (GCP) General Principles and . . .

ICH E6(R3) Guideline reaches Step 4 of the ICH Process

ICH E6(R3) reaches Step 4 of the ICH Process on 6th January 2025. The guideline . . .

U.S. Food & Drug Administration: Draft Guidance for Industry and Other Interested Parties

The U.S. Food and Drug Administration has issued its first guidance on the use of . . .

ACDM DMEG News: Regulatory Updates and Forthcoming Challenges for 2025

As 2024 draws to a close, the Regulatory Considerations Data Management Expert Group . . .

Audit Trail Review DMEG Update – New Guide

The Audit Trail Review (ATR) DMEG has been hard at work putting the finishing touches on a . . .

Risk Based Quality Management DMEG Update – Recent Discussions

This year our focus has switched away from generalised RBQM to applying risk-based . . .

Regulatory Considerations DMEG Update – September 2024

The Regulatory Considerations DMEG are waiting for the release of ICH GCP E6 (R3) Annex 1 . . .

Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO)

This article has been submitted by Leeni Joshua of ICON plc Introduction: Digital Data . . .

Guidance for Industry: Conducting Clinical Trials With Decentralized Elements

The Conducting Clinical Trials With Decentralized Elements final guidance has now been . . .

Welcome FGK Clinical Research as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome FGK Clinical . . .