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

Updated: September 29, 2020

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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 other public health recommendations. Also, clinical trial staff are being transferred to other duties, which is causing some delays.  

Clinical trials must follow the requirements of the protocol, which is authorized by Health Canada and approved by the Research Ethics Board. This requirement is set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR).

During the pandemic, there may be some protocol deviations. However, it is important to continue to protect patient safety and ensure that data are not compromised.

New trials

Clinical trial applications that investigate how to prevent, mitigate or treat COVID-19 are given priority.

To reduce regulatory burden, we have developed a new regulatory pathway, the interim order for clinical trials for medical devices and drugs relating to COVID-19. Sponsors of clinical trial applications for COVID-19 must indicate if they are filing the application under this new pathway:

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

During a review of a clinical trial application, we may ask for more information. If a sponsor is unable to respond within the requested timeline, they should consider:

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 protocol or status of the study should consider:

Plans to add extra study sites and recruit more people may need to be halted.

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

Participants

Guidelines for the management of clinical trial participants are as follows:

For COVID-19 testing and screening:

For informed consent:

Participants with COVID-19

Sponsors must decide quickly whether the participation of someone affected by COVID-19 should be:

Notify Health Canada of any participant who contracts COVID-19 during the study. Carefully consider whether you should put in place additional mitigation measures or suspend the trial.

Site changes

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 any identifiers leaving the original site and be assured that their confidentiality will be protected.

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

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:

You will not need to submit a protocol amendment.

Make sure to:

Sample collection and storage

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

Distribution of product

The shipment of clinical trial investigational products from Canadian sites directly to patients is not prohibited under the Food and Drug Regulations (FDR). 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 our guidelines for temperature control of drug products during storage and transportation (GUI-0069).

Make sure that:

Protocol deviations

For clinical trial sites:

For sponsors:

For detailed guidance on complying with the regulations, please see our guidance for Part C, Division 5 of the FDR “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100).

Contact us

For questions about this notification or the regulation of clinical trials, 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:
Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
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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