Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors

From: Health Canada
Updated: May 6, 2021

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Overview

The COVID-19 pandemic is having an impact on how clinical trials are being conducted. For example, people participating in trials must practise physical distancing and follow other public health recommendations. Also, clinical trial staff are being transferred to other duties, which is causing some delays.

As set out in paragraph C.05.010(b) of the Food and Drug Regulations, clinical trials must follow certain requirements of the protocol. Health Canada authorizes this protocol and the Research Ethics Board approves it.

During the pandemic, there may be more deviations from the established protocol. Despite this, it’s important to continue to protect patient safety and ensure data integrity.

This notice addresses the concerns of clinical trial sponsors and Canadians. We may update this notice as the pandemic evolves and will continue to provide current information to all stakeholders.

Trials

New trials

Sponsors may continue to file COVID-related or other clinical trial applications and amendments according to Health Canada guidance.

During our review of a clinical trial application, we may ask for more information, as outlined in paragraph C.05.009 of the Regulations. If a sponsor is unable to respond within the requested timeline, they should consider withdrawing their application. Sponsors may re-file without prejudice when they have the required information.

For sponsors wishing to file a COVID-19-related trial:

Ongoing trials

Sponsors of a current trial must document the measures they took to stop or lower the risk of becoming infected with COVID-19. Any changes to the approved protocol or status of the study should consider:

Sponsors who cancel a trial or temporarily stop or halt recruitment should:

If a study is temporarily stopped or halted, sponsors should submit a new CTA-N to inform Health Canada when the study resumes.

Participants

Guidelines for managing clinical trial participants are as follows:

For COVID-19 testing and screening:

Participants with COVID-19

Sponsors must decide whether to:

For someone who contracts COVID-19 while taking part in a study at Canadian sites:

The sponsor should submit a notification if they made any changes to the study as a result.

You should consider and discuss with your research ethics board whether you should put in place extra mitigation measures or halt or postpone the trial.

Informed consent

When consent can’t be obtained in person, sponsors should consider other methods, such as over the telephone, or using fax, Skype or video-teleconferencing.

Sponsors should consider the following:

Changing sites

The physical site where visits are held may have to be changed. This may cause confidentiality issues around the participant’s medical records (electronic health record).

Trial participants will need to consent to the transfer of any identifiers from the original site and be assured that their confidentiality will be protected.

For alternative sites for laboratories, diagnostic imaging, and so on:

Reporting an adverse event

Sponsors are expected to continue reporting suspected unexpected serious adverse reactions. The requirements for doing so are set out in C.05.014 of the Regulations.

Phase IV trials continue to fall outside the scope of Division 5.

Monitoring

Assess whether other safety assessment methods are possible when participants are unable to come to the investigational sites as specified in the study protocol.

If alternative monitoring is done, careful documentation will be required to capture:

Sponsors will not need to submit an amendment to the protocol.

Make sure to:

Collecting and storing samples

Always treat human biospecimens as potentially infectious. Follow your biosafety protocols.

Distributing a product

It’s allowed to ship clinical trial investigational products from Canadian sites directly to patients under the Food and Drug Regulations.

Product formulations that are acceptable for direct shipment are:

When transporting, handling and storing investigational products, make sure to reduce the risk of exposure to temperatures outside labelled storage conditions. Please see Health Canada’s guidelines for temperature control of drug products during storage and transportation (GUI-0069).

Make sure that:

Deviating from protocol

For clinical trial sites:

For sponsors:

For detailed guidance on complying with the regulations, please see the guidance for Part C, Division 5 of the FDR “drugs for clinical trials involving human subjects” (GUI-0100).

Submitting regulatory activities

The COVID-19 pandemic has presented challenges to sponsors who file clinical trial applications (CTA) and amendments (CTA-A). 

As an interim measure, CTA(-A)s may be submitted via email to the Therapeutic Products Directorate (TPD) and the Biologics and Radiopharmaceutical Drugs Directorate (BRDD). Email your submissions as follows:

Sponsors may use these email addresses until they are able to return to regular working conditions or until further notice by Health Canada. Please note the following email restrictions:

If a CTA(-A) is larger than 20 megabytes, the CTA(-A) may be split and sent under separate emails (for example, 1 email for module 1 and 1 email for modules 2 and 3). The subject lines of the emails should clearly link to one another (for example, “Email 1 of 2: CTA(-A), [Product Name], [Protocol Number]”).

Remember that email is not considered a secure method of transmission.
The relevant directorate will aim to issue a CTA(-A) acknowledgment letter within 7 days of receipt. 

Contact us

For questions about this notice or the regulation of clinical trials, please contact Health Canada:

For pharmaceutical drugs:

Therapeutic Products Directorate
Office of Clinical Trials
5th Floor, Holland Cross, Tower B
A/L 3105A, 1600 Scott St
Ottawa ON  K1A 0K9
Email: hc.oct.enquiries-requetes.bec.sc@canada.ca

For biologics and radiopharmaceuticals:

Biologic and Radiopharmaceutical Drugs Directorate
Office of Regulatory Affairs
0601C-100 Eglantine Dwy
Ottawa ON  K1A 0K9
Email: hc.brdd.ora.sc@canada.ca

For clinical trial compliance:

Regulatory Operations and Enforcement Branch
Clinical Trial Compliance Program
1903C-200 Eglantine Dwy
Ottawa ON  K1A 0K9
Email: GCP_BPC@hc-sc.gc.ca

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