Regulatory Issues in Clinical Trials

Course Description

Since 2001, clinical trials in Canada have been governed by Regulations under the Food and Drugs Act that include, by reference, the requirement to follow ICH – Good Clinical Practice Guidelines (GCP).

The Research Ethics Project offers a one-day course that describes the obligations of the Canadian Clinical Trials Regulation and GCP suitable for principal and other investigators, research staff, and research administrative personnel dealing with clinical trials.

The course covers the important provisions of Health Canada, including the Clinical Trial Regulation, ICH-GCP as well as other national and international regulatory sources.  In addition, for investigators doing clinical trials for US sponsors, the course can provide an overview of key FDA regulations.  Topics include:

  • Scope and application of clinical trial obligations
  • Background and principles of ICH GCP
  • Obligations of the sponsor
  • Qualification and obligations of investigators
  • CTA application, authorization and notification requirements
  • Requirements for protocols and protocol amendments
  • Requirements relating to research ethics (REB) review
  • Data handling and record-keeping
  • Adverse event and adverse drug reaction reporting
  • Further obligations for the conduct of clinical trials
  • Cancellation, termination and suspension of a trial

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