Objectives:

  • To provide a means for certification of Canadian clinical research professionals.
  • To promote an understanding of Canadian regulations.
  • To create a process for credentialing by a professional Canadian group.
  • To create a platform of recognition for Canadians working in clinical research located in Canada and around the world

Candidates for Exam:

  • Personnel implementing clinical trials in Canada, including clinical research associates (monitors), clinical research coordinators, investigators and other relevant research-related professionals.

Eligibility for taking the examination:

  • Knowledge of GCP, TCPS and Canadian and US regulations pertaining to clinical trials as well as basic knowledge of EU regulations pertaining to clinical trials (see details below*) along with a working knowledge of clinical trial design, study organization and quality assurance of studies AND
  • Experience:
    • At least 2 years’ experience over the past 5 years in clinical research – could be done part time for total of 3500 hours as well with at least 1 year of Canadian experience OR
    • If you have a post-graduate certificate (i.e. you have an undergraduate degree) in clinical research plus at least 1 years’ experience over the past 2 years in clinical research with at least 1 year of Canadian experience

*Knowledge required:

  • The Declaration of Helsinki
  • The Tri-Council Policy Statement
  • Health Canada Division 5 guidelines
  • ICH GCP guideline for Good  Clinical Practices
  • 21 US Code of Federal Regulations, Parts 11, 50, 56, 312 and 812
  • 45 Code of Federal Regulations- Part 46
  • European Union Clinical Trials Directive (basic understanding)