- 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
- 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
- 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)