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Navigating Canadian Regulations for Oncology Clinical Research – Part II


Navigating Canadian Regulations for Oncology Clinical Research
Your Questions Answered Part II

Senior executives from oncology drug developers looking to mitigate recruitment risks for their ongoing or upcoming trials and are considering Canada as a solution are looking for answers to their questions.

This post is Part II of a two-part series summarizing 5 more answers that respond to 10 frequently asked questions by U.S. drug developers about oncology clinical research in Canada.

6) Is it necessary to have a drug depot located in Canada?
No. It is possible to ship study drugs from a US depot to Canada, as long as the necessary information is included in each study drug shipment. This same requirement applies to other study materials, such as laboratory kits.

7) Can Canadian Sites ship biological samples to the US?
Canadian Sites are equipped to and experienced in shipping study biological samples from Canada to a US location (ex: central laboratory). FedEx is a preferred courier since most Canadian hospital and Research Centers have a FedEx pick-off/drop-off desk onsite, thereby facilitating timely shipments of study samples to the US.

8) Are there Site-level Health Canada forms to be completed and/or submitted to Health Canada prior the commencement of a clinical trial?
A Qualified Investigator Undertaking form (QIU), as well as a Clinical Trial Site Information (CTSI) Form must be completed prior to commencement of the trial. In addition, the Site should have received study approval from an appropriate local ethics committee. If the ethics committee’s approval documentation does not include a statement of compliance with the membership requirements for REBs defined in the Regulations (section C.05.001), the Research Ethics Board Attestation (REBA) form also needs to be completed. Solely the CTSI form needs to be submitted to Health Canada prior to trial commencement, unless the appropriate Health Canada Directorate specifically requests copies of the QIU or REBA forms.

9) Do study documents need to be translated into French in Canada?
Some Canadian centers see patients who speak languages other than English. A vast majority of Canadian centers will accept to work from an English Informed Consent Form for the initial submission to their local ethics board, and final approved templates may be translated once final ethics approval is obtained, thereby expediting and simplifying the process. In addition, any documentation to be presented to patients (ex: patient diary, quality of life questionnaire, etc.), must also be translated into the patients’ spoken language (as required) and approved by the local ethics boards.

Health Canada does not require receipt of a translated Master Informed Consent as part of the CTA; an English version will suffice. In any case, an effective Canadian oncology CRO should readily and promptly be capable of Canadianizing any US Master Informed Consent Form in order to comply with Canadian laws and application requirements, prior to the CTA submission to Health Canada.

10) Do drug labels need to be modified for Canadian Sites?
Labelling of clinical trial drug supplies must conform with section C.05.011 of the Food and Drug Regulations. Study drug labels do not need to be submitted as part of the clinical trial application unless specifically requested by the appropriate Health Canada Directorate.

Labels for study drugs to be used for a clinical trial conducted in Canada must bear the following information in French and in English: a statement indicating that the drug is an investigational drug to be used only by a qualified investigator; the name, number or identifying mark of the drug; the expiration date of the drug; the recommended storage conditions for the drug; the lot number of the drug; the name and address of the sponsor; the protocol code or identification; and if the drug is a radiopharmaceutical as defined in section C.03.201.

An experienced Canadian oncology CRO designs drug labels for Sponsors that comply with Health Canada’s requirements while preserving the Sponsors’ original template. Note that in-study re-labelling of study medication can be done on Site.

Contributed by: Julie Martin, Director, Clinical Operations

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