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

On this page

• Informed consent
• Registration

Informed consent

Provide a copy of the informed consent form and information on the informed consent process. Under the Regulations, the qualified investigator has 2 other ways to obtain informed consent when clinical trial subjects are unable to consent in person and in writing:

1. remote written informed consent of an individual who will participate in a COVID-19 medical device clinical trial or
2. non-written informed consent gained by reading the informed consent form to the trial participant and receiving the person's non-written informed consent before a witness, and subsequent attestation, if written informed consent cannot be obtained

Registration

In line with Health Canada policy recommendations and international best practices, clinical trial authorization holders are encouraged to register their clinical trial in public registries such as ClinicalTrials.gov and ISRCTN. We recommend that authorization holders use the World Health Organization's preferred term (COVID-19) in the public or scientific title to make these studies easy to search.

Authorization holders should notify us within 5 days of registering their clinical trial by emailing us at it-ee@hc-sc.gc.ca. In the email, provide the following information:

• clinical trial registry name
• link to clinical trial posting
• registration number (for example, ClinicalTrials.gov identifier - NCT#)

Our list of authorized clinical trials involving COVID-19 medical devices includes a link to this information.