Health Canada Regulations

In this section you will find links to important and useful documents produced by Health Canada which relate to the regulatory functions of the Health Products and Food Branch Inspectorate. This group is responsible for the inspections and investigations of clinical trials in Canada and is closely aligned with the Therapeutic Products Directorate.

Division 5 Regulations

Division 5 of the Food and Drug Regulations is “Drugs for Clinical Trials Involving Human Subjects”. This set of regulations should be reviewed by all study site staff and the completion of this this training documented in study site files.

Guidance for Records Related to Clinical Trials

This is a guidance document for the interpretation of section C.05.012 on clinical trial records under the Food and Drug Regulations Amendment (Schedule No. 1024) “Drugs for Clinical Trials Involving Human Subjects”. This document outlines the interpretation of the specific requirements for records and record retention related to the conduct of clinical trials in Canada for Sponsors, Qualified Investigators (QI), and Research Ethics Boards (REB) involved in clinical trials under the purview of the Regulations.

Good Clinical Practice Consolidated Guideline

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.