Regulatory Framework for Conducting Clinical Research in Canada

Area of Science:

• Health outcomes research
• Clinical trial conduct
• Human subjects research

Background:

• Improving health outcomes relies on human subjects research.
• Ensuring clinical trial data quality and subject safety is paramount.
• Canada lacks a single, definitive law governing human research.

Purpose of the Study:

• To provide an overview of Canadian legislation, guidelines, and policies for clinical trial research.
• To clarify the interrelationship between various regulatory agencies.
• To facilitate clinical trial investigators and enhance public health.

Main Methods:

• Review of federal legislation, including Food and Drug Regulations.
• Examination of the Tri-Council Policy Statement (TCPS2).
• Overview of provincial legislation and institutional policies.

Main Results:

• A network of federal, provincial, and institutional regulations governs clinical trials in Canada.
• Researchers face challenges navigating this complex regulatory environment.
• Information on interrelationships between regulatory agencies is scarce.

Conclusions:

• A comprehensive understanding of the regulatory framework is essential for effective clinical trial conduct.
• Facilitating investigator navigation can improve clinical trial research in Canada.
• Enhanced understanding supports the long-term health of Canadians.