Canada (V2)

DCT Feasibility Assessment Canada (V2) 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. Disclaimer...

Health Canada administers, develops, and enforces acts and regulations as part of the legislation. This federal government department consults with the Canadian public industry, non-governmental organizations, and other interest parties in the deve...

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 risk...

As described in  section 2.2 , in Canada, EC and IRB (Institutional Review Boards) are referred to as Institutional Ethics Committee (IEC) and Research Ethics Boards (REB). 3.1  Provide a list of documents needed to be submitted...

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 radiopharmaceuti...

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

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

Clinical Trials Ontario, a not-for-profit organization, has collated a resource guide for the conduct of DCTs, which is a useful indicator of DCT processes throughout Canada due to the currently “opaque” requirements of Health Canada and the REBs....

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

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

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...

Legislation Food and Drugs Act RSC, 1985 Food and Drug Regulations CRC, c870 Personal Information Protection and Electronic Documents Act (S.C. 2000, c.5) Privacy Act (R.S.C., 1985, P-21) Human Pathogens and Toxins Act SC 2009, c2...

Hyperlinks to pdf versions of relevant forms and templates, including instructions for completion, and useful internet websites, are available under the heading “Forms and Templates” here Adverse Drug Reactions (ADRs) for Clinical Trials – Expe...