Principles of Clinical Research I (CRCR130) is part of the Clinical Research Program. This course is for healthcare professionals interested in clinical research that need to develop the basic skills for a clinical trial environment.

Learners will begin their development as a member of the clinical research team through the study of clinical research good clinical practices and the development of practical skills in clinical trials. During this process, learners will acquire the core skills required to become a part of the clinical research team.

The course introduces learners to the role of clinical trials and research in the health care sector and in industry. The phases and elements of clinical trials will be considered and current issues relating to clinical research will be discussed.

Topics covered include:

• History of Clinical Research
• Roles and responsibilities of key personnel involved in clinical research
• Role of clinical research in the development and marketing of therapeutic interventions
• Elements of a clinical trial
• Phases and types of clinical trials
• Terminology associated with clinical trials
• Importance of regulations relating to the conduct of clinical trials [ICH, FDA, TPD]
• Good Clinical Practices Guidelines
• Recruiting study subjects
• Requirements for the reporting of Adverse Events

NOTE: If you are currently working in clinical research you may be eligible for a Prior Learning Assessment for the course Principles of Clinical Research I- CRCR130. Please contact ce@michener.ca for more information.

Upon successful completion of the course, learners will be able to:

• Explain the drug development process
• Describe the Canadian drug review process
• Describe the elements of a clinical trial
• Describe the roles and responsibilities of personnel and organizations involved in clinical trials
• Understand and use the terminology associated with clinical research trials
• List and describe the importance of the regulations relating to the conduct of clinical trials (ICH, Health Canada (Division 5), and FDA)
• Explain the ethical principles governing clinical research
• Describe Good Documentation Practices
• Understand Electronic Data Capture (EDC) Principles
• Describe the primary aspects of privacy and protection of personal information as related to clinical research
• Discuss recruiting challenges and strategies
• Describe the requirements for collecting and reporting of Adverse Events in clinical trials