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

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• Good clinical practices
• Qualified investigator
• Labelling

Good clinical practices

Authorization holders have overall responsibility for conducting the clinical trial in accordance with the principles of good clinical practice. These principles are in place to protect the rights, safety and well-being of clinical trial participants and others. The Regulations are generally consistent with internationally recognized good clinical practices (ICH E6(R2)). Where there are inconsistencies, section 28 of the Regulations takes precedence.

Section 28 (good clinical practices) of the Regulations applies to COVID-19 drug clinical trials authorized under the Regulations. For guidance on how to meet the requirements of this section, authorization holders are encouraged to consult section 5.10 of the following guidance document:

• Part C, Division 5 of the Food and Drug Regulations - Drugs for clinical trials involving human subjects (GUI-0100)

The Regulations include the following changes from the FDR:

• qualified investigator includes other qualified health professionals, in addition to physicians and dentists
• alternate means of obtaining informed consent in the context of COVID-19 can be allowed beyond written consent (refer to the next section)

Qualified investigator

Health Canada has expanded the list of regulated health care professionals who are responsible to conduct a clinical trial at a clinical trial site. Along with physicians or dentists, other licensed health care practitioners, such as nurse practitioners, pharmacists and midwives who meet the definition in section 1 of the Regulations, have now been included.

Expanding this list offers greater flexibility to conduct decentralized trials, where other health care providers may be more available to conduct trials at remote sites.

Study participants should, nevertheless, have access to medical services in the event that issues arise that require a physician or dentist.

Labelling

Existing labelling requirements under section C.05.011 of Division 5 of the FDR have been carried over to section 33 of the Regulations.

Authorization holders will, therefore, be responsible for labelling a COVID-19 drug for testing in the clinical trial in accordance with these requirements, including in both official languages. The exception is if they are studying off-label use of marketed drugs and have been exempted (refer to Clinical trial involving new uses of a marketed drug).

For information on labelling requirements, refer to section 5.11 of the following guidance document:

• Part C, Division 5 of the Food and Drug Regulations: Drugs for clinical trials involving human subjects (GUI-0100)