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The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical requirements for CTAs pursuant to Division C.05 of the Food and Drug Regulations.

The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides guidance on the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects.

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

Depending on the type of clinical trial, sponsors may be required to file a Clinical Trial Application (CTA) for human drug clinical trials. Instances where a CTA must be filed are summarized in the chart below.

Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Guidance documents for management of drugs for clinical trials involving human subjects. The sponsor must ensure that the clinical trial is conducted in accordance with the requirements of the protocol, which has been authorized by Health Canada and approved by REB(s).

This Notice serves to inform clinical trial sponsors that Health Canada will publish information about all clinical trial applications (CTAs) authorized as of April 1, 2013, for the study of drugs in patients.

Health Canada is issuing this guidance for clinical trials in type 2 diabetes to provide clarification on the interpretation of the Canadian Diabetes Association Clinical Practice Guidelines (CDA-CPG)Footnote1 in relation to clinical trial applications under Part C, Division 5 of the Food and Drug Regulations.