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

On this page

• 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. IO No. 2 is generally consistent with internationally recognized good clinical practices (ICH E6(R2)). Where there are inconsistencies, section 28 of IO No. 2 takes precedence.

Section C.05.010 (good clinical practices) of Division 5 of the Regulations applies under IO No. 2 for COVID-19 drug clinical trials (section 28). Authorization holders are encouraged to consult section 5.10 of the guidance document Part C, Division 5 of the Food and Drug Regulations - Drugs for clinical trials involving human subjects (GUI-0100) for guidance on how to meet the requirements of this section.

Note: The following changes have been made under IO No. 2:

• qualified investigator includes other qualified health professionals
• alternate means of obtaining informed consent in the context of COVID-19 can be allowed beyond written consent (see below)

Qualified investigator

We have expanded the list of regulated health care professionals who are responsible to conduct a clinical trial at a clinical trial site. In addition to physicians or dentists, other licenced health care practitioners, such as nurse practitioners, pharmacists and midwives, have now been included.

Expanding the 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.

Labelling

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

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 (see Clinical trial involving new uses of a marketed drug).

For information on labelling requirements, refer to section 5.11 of the Guidance document: Part C, Division 5 of the Food and Drug Regulations - Drugs for clinical trials involving human subjects (GUI-0100).