ARCHIVED Guidance on applications for drug clinical trials under the interim order: General requirements

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• Informed consent
• Registration

Informed consent

Section 36 of IO No. 2 gives 2 alternate means for the qualified investigator to obtain informed consent when clinical trial participants are unable to consent in person and in writing:

• remote written informed consent of an individual who will participate in a clinical trial involving a COVID-19 drug or
• non-written informed consent obtained through reading the contents of the informed consent form to the trial participant and receiving the individual's informed consent before a witness, and subsequent attestation by the witness that the consent was given

Note: Reference to section 36 in IO No. 1 has been removed from paragraph 28(h) of IO No. 2 (good clinical practices requirements). This was done to clarify that informed consent is given with applicable laws governing consent. This already captures the alternate means of informed consent as described in section 36.

Registration

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. Health Canada encourages holders to register their trial in a public registry such as ClinicalTrials.gov 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 (see Who to contact for contact information). Provide the following information:

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

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 and clinical trial database.