As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority responsible for clinical trial approvals, oversight, and inspections in Canada.
Who regulates clinical trials in Canada?
All clinical trials, regardless of purpose or investigational product require review and approval by an independent Research Ethics Board (REB). Health Canada and the Research Ethics Board review the application and decides on whether to accept or reject the application.
Who is responsible to conduct clinical trials?
Principal Investigator
A Principal Investigator (PI) is the person in charge of conducting a clinical trial. The PI is responsible for ensuring that the study is following all regulatory requirements and meeting the internationally recognized standards for Good Clinical Practice (GCP).
Who is responsible for submitting the clinical trial application to Health Canada?
2.3 Clinical Trial Applications (CTAs) The sponsor must file a CTA prior to the initiation of the trial [C. 05. 005].
What is a clinical trial in Canada?
Clinical trials are studies to find out whether a drug is safe and effective for people. The people who take part in trials are volunteers. They may be: patients with a disease.
What is the Canadian equivalent of the FDA?
Health Canada’s HPFB is the national authority that regulates, evaluates and monitors the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians. These products include drugs, medical devices, disinfectants and sanitizers with disinfectant claims.
Does the FDA have authority in Canada?
SUMMARY. Health Canada is the federal body that regulates the drug approval process under the Food and Drugs Act (FDA) and its regulations (FDR), its related policies and guidance.
Do doctors conduct clinical trials?
Where are clinical trials conducted? Clinical trials can be sponsored by organizations (such as a pharmaceutical company), Federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers).
What are the 4 types of clinical trials?
Types of clinical trials
- Pilot studies and feasibility studies.
- Prevention trials.
- Screening trials.
- Treatment trials.
- Multi-arm multi-stage (MAMS) trials.
- Cohort studies.
- Case control studies.
- Cross sectional studies.
What does a CRA do in clinical research?
What are the responsibilities of a clinical research associate? Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.
How many clinical trials are there in Canada?
Every year, Health Canada authorizes approximately 900 clinical trials in patients.
How do I start a clinical trial in Canada?
The sponsor of most clinical trials must file a clinical trial application (CTA) with Health Canada in order to conduct the trial. Health Canada will review the application and either approve or reject it within 30 days.
What is the difference between a clinical trial and a clinical study?
Clinical Trial
Clinical studies, on the other hand, are more generalizable and can include both interventional and non-interventional studies; however, clinical studies DO NOT involve investigational medicinal products (IMPs), as opposed to clinical trials.
Can you get paid for clinical trials in Canada?
Canada’s Strategy for Patient-Oriented Research (SPOR) encourages researchers and research partners to offer payment to patients who act as partners in research and research-related activities.
What are the three different stages of a clinical trial?
Phases of Clinical Trials
- Phase I trials test if a new treatment is safe and look for the best way to give the treatment.
- Phase II trials test if one type of cancer responds to the new treatment.
- Phase III trials test if a new treatment is better than a standard treatment.
Is Health Canada more strict than the FDA?
Past studies have shown that Health Canada both takes longer to approve medicines (from the time of submission) and approves fewer medicines than its American and European counterparts.
Who approves medical devices in Canada?
Health Canada
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.
Who regulates GMP in Canada?
Health Canada
To ensure compliance with GMP regulations, Health Canada inspects establishments that fabricate, package or label, distribute, import, wholesale or test drugs. During these inspections, Health Canada verifies compliance with good manufacturing practices (Part C, Division 2 of the Food and Drug Regulations).
Are pharmaceutical companies federally regulated in Canada?
Pharmacy in Canada is one of many self-regulating professions. This means that the federal and provincial/territorial governments have delegated their authority to regulate certain professions to external bodies, whereby the professions regulate themselves.
Do you need an MD to do clinical trials?
Medical School typically takes 4 years to complete, and PhD programs can last anywhere from 5 to 6 years, depending on how long it takes to complete a dissertation. Students do not need a medical degree to become involved in clinical research.
Do pharmaceutical companies run clinical trials?
Around the world, pharmaceutical companies conduct clinical trials to evaluate the safety and efficacy of their drugs.