Clinical Data Management News & Insights
Established in 1987, The Association for Clinical Data Management (ACDM) is a Membership Organisation for individuals and organisations involved in the management of clinical data.
Please find below the latest news from ACDM, our members, the CDM community and the wider industry.
Regulatory Considerations DMEG to Review Health Canada’s Draft Guidance
August 4, 2026
Thank you to the Regulatory Considerations DMEG for sharing this update.
Health Canada published a Draft guidance on decentralized clinical trials. This is part of Health Canada’s effort to modernize clinical trial regulation to allow for new trial types and designs. The guidance applies to phase I-IV trials involving pharmaceuticals, biologics and radiopharmaceuticals intended for human use. It does not apply to medical devices, natural health projects or foods for special dietary purposes.
The ACDM Regulatory Considerations DMEG will be reviewing the draft guidance and publishing a summary of the points that impact data managers. In the interim you can read the draft guidance here: Health Canada Draft guidance on decentralized clinical trials or download here.