The use in a clinical trial of new, investigational, drugs requires Health Canada approval, whether the trial is investigator or industry initiated.
Health Canada approval is also required for applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) or Drug Identification Number (DIN) application, including, for example, where one or more of the following is different:
- indication(s) and clinical use;
- target patient population(s);
- route(s) of administration, or
- dosage regimen(s).
Health Canada Review
A Clinical Trial Application (CTA) must be filed with Health Canada prior to the initiation of a clinical trial in Canada.
The Health Canada application includes:
- a protocol which details the objectives, benefits, risks, methods, and conditions for the trial to function
- Clinical Trial Site Information Form
- Clinical Trial Application (CTA)
- Qualified Investigator Undertaking
- Protocol Synopsis and Evaluation
- Research Ethics Board Attestation (if available at the time of submission)
All necessary forms, information and guidance documents are available at:
Of particular importance is the document entitled Guidance for Clinical Trial Sponsors: Clinical Trial Applications.
Health Canada normally reviews the application and notifies the Sponsor within 30 days if the application is found to be deficient.
Clinical Trial Application requirements are outlined in the Food and Drugs Act and Regulations, the Guidance for Clinical Trial Sponsors: Clinical Trial Applications document and Clinical Trial Application form, all available at the web site identified above. These documents also explain the requirements pertaining to local Research Ethics Board review and approval of clinical trials.
Institutional/Investigator-initiated CTAs must comply with the same regulatory requirements that apply to Industry-initiated CTAs, with some modification as outlined in the Guidance for Clinical Trial Sponsors: Clinical Trial Applications document referenced above.
If there is any uncertainty as to whether Health Canada approval is required, the researcher is encouraged to contact Health Canada at:
Senior Medical Advisor Bureau
Telephone: (610) 954-6493
Fax: (610) 954-4474
University of Ottawa Ethics Review
Whether your clinical trial requires authorization or not from Health Canada, you must submit an ethics application to either the Health Sciences and Science Research Ethics Board (REB) of the University of Ottawa or, as appropriate, to the REB of one of the University of Ottawa’s affiliated hospitals.
Approval from the Research Ethics Board of the Qualified Investigator’s hospital must also be obtained concurrently with or prior to submission to the Health Sciences and Science Research Ethics Board (REB) of the University of Ottawa. If the Qualified Investigator is not associated with one of the University of Ottawa’s affiliated hospitals, please contact the Ethics office at the address indicated below.
For applicable studies:
- You must submit the Clinical Trial Application to Health Canada for its approval before submitting an application for ethical review to the appropriate Research Ethics Board (REB) at the University of Ottawa or one of the University of Ottawa’s affiliated hospitals;
- You must include a copy of the Clinical Trial Application to Health Canada in the ethics application;
- The REB must receive a copy of the No Objection Letter (NOL) from Health Canada prior to the REB releasing the final certificate of approval.
For further information on the University of Ottawa Ethics review process, please contact:
Information for Investigators
All clinical researchers must be familiar with the details of the Regulations Amending the Food and Drug Regulations (1024 – Clinical Trials). These regulations apply to clinical trials for both new, investigational, drugs and some marketed drugs.
There must be ONE Qualified Investigator at each clinical trial site, who is responsible for the medical decisions and care provided to clinical trial subjects. A Qualified Investigator must be a licensed physician or dentist (for dental studies).
The Qualified Investigator must sign an undertaking that he/she will conduct the trial according to Good Clinical Practices.
- Health Canada requires that all clinical trial records be maintained for a period of 25 years.
- Documentation must include a Research Ethics Board Attestation that “for each clinical trial site, an attestation, signed and dated by the Research Ethics Board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner “consistent with good clinical practices.” A “Research Ethics Board Attestation” form is available at the above web site for this purpose.
- More detailed information is provided in Health Canada’s Guidance for Clinical Trial Sponsors: Clinical Trial Applications document.