Guidance on applications for COVID-19 drug clinical trials under the Regulations: General requirements

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Informed consent

Section 36 of the Regulations gives 2 alternate means for the qualified investigator to obtain informed consent when clinical trial participants are unable to consent in person or in writing:


In line with existing Health Canada policy recommendations and international best practices on being transparent, the authorization holder should register their COVID-19 clinical trial after authorization has been issued. We encourage holders to register their trial in a public registry such as and ISRCTN. Use the World Health Organization's preferred term (COVID-19) in the public or scientific title to make these studies easy to search.

The authorization holder should notify the appropriate directorate by email within 5 days of registering their trial. Be sure to include "COVID-19 clinical trial registration" in the subject line (refer to Who to contact for contact information). Provide the following information:

We will use this information to maintain a list of authorized clinical trials on COVID-19 on our vaccines and treatments for COVID-19 website.

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