10. Roadmap of the Submission Process of a Clinical Trial

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 following schematic illustration.

The areas Health Canada proposes to modernize are described in Figure 2 below.

Table 1 elaborates on the Categories of trials which would not require authorization, once Health Canada assumes a risk-based approach.

https://capra.ca/en/blog/health-canadas-proposal-for-clinical-trials-regulatory-modernization-2021-07-16

10.2 Pediatric Investigation Plan

KidsCAN Trials has been established as a national hub to coordinate research in the safe therapeutic use of medicines for children. In partnership with Paediatric Emergency Research Canada, four pediatric trials are underway, to serve as proof of concept to develop the design, conduct, and reporting of pediatric clinical trials. The process described in section 10.1 above provides a generic roadmap of clinical trials in Canada, pending its regulatory modernization of pediatric trials.

https://www.kidscantrials.ca/trials

10.3 Clinical Study (Interventional or Observational)

Information can be found in section 10.1 above. The determination of whether or not a study requires regulatory authorization will depend on its scope and the category into which it may fall.