Management Of Clinical Trials During The COVID-19 Pandemic

Health Canada is aware of the impact of the pandemic on the conduct of clinical trials, including the need for:

• participants to self-isolate
• deployment of healthcare personnel involved in clinical trials to other duties during this public health emergency, resulting in delays in completing certain tasks.

As per paragraph C.05.010(b) of the Food and Drug Regulations (FDR), the sponsor must ensure that the clinical trial is conducted in accordance with the requirements of the protocol, which has been authorized by Health Canada and approved by REB(s).  Health Canada recognizes that there may be an increase in protocol deviations during the COVID-19 pandemic.

The clinical trial site(s) should have a system in place to identify, document, assess and report all protocol deviations to the sponsor and REB in accordance with   sponsor and REB requirements.  These deviations need to be documented, to facilitate future analysis of the study findings.  The sponsor should define and identify the protocol deviations to be reported.  Unless the deviations may place participants at risk, sponsors will not be required to report these deviations to Health Canada.

Monitoring activities may need to be re-assessed, and should prioritize critical activities to ensure participant safety.  It is advisable to document any changes and their impact. Processes may need to be changed: for example, an electronic alternative may have to be considered in place of a wet ink signature.

Eligibility assessment is to be carried out as usual.  Persons should not enroll in a trial if they do not meet the pre-set inclusion/exclusion criteria.  If by missing a pre-defined study visit, the safety of a participant may be put at risk despite implementation of appropriate mitigation measures, the sponsor needs to consider having the participant discontinue taking part in the study.

Halting recruitment or temporarily halting the trial may be required in some circumstances.  If this happens, sponsors are to inform Health Canada using a clinical trial application notification (CTA-N).

The FDR do not prohibit the shipment of clinical trial investigational products (IP) from Canadian sites directly to patients. This approach would be acceptable for all product formulations (e.g., tablets, injectables); however, the following considerations and/or requirements should be kept in mind:

• This approach can only be considered for drugs that a subject could take on their own (e.g., subject already in a trial and on medication, and if the trial uses a medication that doesn’t have to be administered in a hospital/clinic setting or have any special conditions for handling).
• Record keeping must comply with regulatory requirements of section C.05.012 of the FDR. As per C.05.012(3)(e), the sponsor must maintain complete and accurate records in respect of the use of a drug in a clinical trial, including records respecting the shipment, receipt, disposition, return and destruction of the drug.
• The trial must always be conducted in accordance with Good Clinical Practices (GCP) and must comply with regulatory requirements of section C.05.010 of the FDR. It is the sponsor’s responsibility to ensure that the drug is administered in accordance with these Regulations.
• Products must be transported, handled and stored in a manner that mitigates the risk of exposure to temperatures outside labelled storage conditions (please refer to the Health Canada Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069)).

For detailed guidance on how to comply with Part C, Division 5 of the FDR, please refer to the Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100).

If you have any questions regarding this notification or regulation of clinical trials, please do not hesitate to contact Health Canada at the following address:

For pharmaceutical drugs:

Therapeutic Products Directorate Office of Clinical Trials 5th Floor, Holland Cross, Tower B A/L 3105A 1600 Scott Street Ottawa, Ontario Canada K1A 0K9 Email: [email protected]

For biologics and radiopharmaceuticals:

Office of Regulatory Affairs Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway, Address Locator: 0601C Ottawa, Ontario Canada K1A 0K9 Email:  [email protected]

For clinical trial compliance:

Regulatory Operations and Enforcement Branch (ROEB) Clinical Trial Compliance Program 200 Eglantine Driveway, Address Locator: 1903C Ottawa, Ontario Canada K1A 0K9 Email: [email protected]