RegulationsHealth Canada
Qualified Investigator Responsibilities The Clinical Trial Application (CTA) for drugs/radiopharmaceuticals/natural health products or the Investigational Testing Authorization (ITA) for devices must be filed with the appropriate directorate within the Health Protection and Food Branch of Health Canada. Clinical Drug Trials The Food and Drug Regulations provide authority to the Therapeutics Products Directorate (TPD) of the Health Products and Food Branch (HPFB) within Health Canada to regulate the conduct of research using investigational drugs for the purposes of use in human clinical trials. Division 5 of the Regulations defines specific Clinical Trial Application (CTA) requirements and prescribes a 30-day default review period for these applications. Amendments to Division 5 were announced in June 2001 and took effect September 1, 2001. Obligations of the Sponsor for Sponsor-initiated Trials: Sponsors must file applications to conduct clinical trials in Phases I through III of drug development. This includes 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, e.g. if one or more of the following is different:
A CTA must be filed prior to the initiation of a clinical trial in Canada. HPFB must review the application and notify the Sponsor within 30 days if the application is found to be deficient or else the Sponsor may proceed. Obligations of the Investigator for Institutional/Investigator-initiated Clinical Trials: Investigators must also comply with the same regulatory requirements that apply to Sponsor*-initiated CTAs, with some modification as outlined in the Guidance for Clinical Trial Sponsors. Obligations of the Investigator for Any Clinical Trial: For any clinical trial, 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. The qualified investigator must sign the Qualified Investigator Undertaking that he/she will conduct the trial according to Good Clinical Practices as documented in the ICH Good Clinical Practice: Consolidated Guideline (1997). CTA requirements are outlined in the Guidance for Clinical Trial Sponsors document and Clinical Trial Application form, including the requirements pertaining to local Research Ethics Board review and approval of clinical trials. Clinical Natural Health Product Trials Part 4 of the Natural Health Product Regulations under the Food and Drug Act governs the conduct of clinical trials using natural health products that are being developed for therapeutic purposes and has the same requirements as that of clinical drug trials with respect to sponsor and investigator obligations. Clinical Medical Device Trials Part 3 of the Medical Device Regulations under the Food and Drug Act - Medical Devices For Investigational Testing Involving Human Subjects governs the use of medical devices for clinical device trials. United States Researchers who receive funding for clinical trials conducted by a U.S. government department and/or its agencies (e.g. Department of Health and Human Services (DHHS)/National Institute of Health/National Cancer Institute, Department of Defence, U.S. Army) OR are conducting studies regulated by the Food and Drug Administration are subject to the pertinent U.S. federal regulations. These are part of the Code of Federal Regulations (CFR) of the United States federal government. The U.S. regulations that pertain to clinical research are:
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