ARCHIVED Guidance on applications for medical device clinical trials under the interim order: General requirements
Notice to Reader:
We have replaced the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19. See the regulations notice about the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
On this page
Informed consent
The interim order enables the qualified investigator 2 alternate means of obtaining informed consent when clinical trial subjects are unable to consent in person and in writing:
- remote written informed consent of an individual who will participate in a COVID-19 medical device clinical trial or
- non-written informed consent through reading the contents of the informed consent form to the trial participant and receiving the individual's non-written informed consent before a witness, and subsequent attestation, if written informed consent cannot be obtained
Registration
In line with existing 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. Authorization holders are recommended to 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 Health Canada at it-ee@hc-sc.gc.ca within 5 days of their registration. Provide the following information:
- clinical trial registry name
- link to clinical trial posting
- registration number (for example, ClinicalTrials.gov identifier - NCT#)
Health Canada maintains a list of authorized clinical trials involving COVID-19 medical devices.