Canada

DCT Feasibility Assessment Canada The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Canada in relation to the Decentralized Clinical Trials (“DCTs”) with medicinal products. Health Canada (HC) is the Regulatory Authority in Canada...

2.1 Name of Regulatory Authority Health Canada (HC), a federal government department, is the federal regulator of health products in Canada. HC's mandate is to ensure the provision of high-quality health services and seeks to reduce health ri...

As described in Section 2.2 , in Canada, EC and IRB (Institutional Review Board) are referred to as Institutional Ethics Committee (IEC) and Research Ethics Boards (REB). There is a central as well as a local REB. QIs should use their local REB. I...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  Whether the clinical trial involves the use of pharmaceutical, biological, and radiopharmac...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   The Qualified Investigator (“QI”) must be a physician in good standing with a professional medical association and is responsible ...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Please refer to Section 2.7 of this guidebook. 6.2 Does local regulation require any separate consent for biological specimen collection, s...

The Government of Canada issued temporary interim orders (“IOs”) , and again on 3 May 2021, to provide flexibility in order to enable the conduct of clinical trials on medical devices and drugs related to Covid-19 during the pandemic. The applicati...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The Office of the Privacy Commissioner of Canada provides advice and information for individuals about protecting pe...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? Yes , subject to certain conditions. Participant-driven approaches must imp...

10.1 Clinical Trial with Investigational Medicinal Product The Canadian Association of Professionals in Regulatory Affairs has collated Health Canada’s proposed modernization of its regulatory framework for clinical trials, described in the f...

1. Health Canada main page https://www.canada.ca/en/health-canada.html   2. Food and Drugs Act_RSC,1985 (last amended 22 Dec 2023) https://laws-lois.justice.gc.ca/eng/acts/f-27/   3. Food and Drug Regulation CRC, c870 (last amended ...

Hyperlinks to PDF versions of the below relevant forms and templates, including instructions for completion, and useful internet websites, are available under the heading “ Forms and Templates ” within the Health Canada website:   Adver...