This course is designed to provide clinical research professionals with the basics of Good Clinical Practices. The course can be used to fulfill the Health Canada GCP training requirements, either as initial training or as a refresher. The content is also suitable as a primer for those interested in clinical research who want to understand the key points.

Learners can expect to dedicate 20 hours to complete the course. Through continuous enrolment, expect a maximum of 6 months to complete the course content.

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

• Explain the history of Good Clinical Practice in clinical research
• Explain the drug development process
• Describe the roles and responsibilities of personnel and organizations involved in clinical trials
• Explain the ethical principles governing clinical research
• Describe the primary aspects of privacy and protection of personal information related to clinical research
• Describe Good Documentation Practices
• Discuss recruiting challenges and strategies
• Describe the requirements for collecting and reporting adverse events in clinical trials
• List and describe the importance of the Health Canada (Division 5) and ICH regulations relating to the conduct of clinical trials