How do drugs and medical devices go from lab to clinical use? What research is required to get them to patients and demonstrate safety and effectiveness along the way? This course allows students to gain knowledge and understanding of the drug development process, the regulatory framework and explore the differences between drugs and medical devices.


  • Legislation on the drug approval process
  • Phases of drug and medical device development
  • The pre-clinical and clinical activities required for drug approval
  • Clinical trial outputs - safety and efficacy data and interpretation

Individual Course Registration

This course is part of the Diploma program and can also be taken as an individual course for non-credit/professional development.  How many courses can you take before you have to apply to the program? 

Diploma Program Progression

Successful completion of first term courses (Minimum 70% average with no single final grade below 65%) is required for progression to second term courses. Successful completion of first and second term courses is required for progression to practicum. 

Applies Towards the Following Certificates


Register - Select a section to enroll in

Sep 09, 2019 to Dec 06, 2019
Total Hours

What to Expect

This is an interactive course; you will engage online with your class and instructor through our online learning management system. Plan to log into your course regularly throughout the week.

You can expect approximately six hours of work per week for discussions, readings, assignments, exams/quizzes and other course requirements.

Completion Requirements

This is a graded course. Evaluation will be based on any combination of participation, exams/quizzes and assignments.


Guide to Clinical Trials, Custom Course Package #M8277 (to be purchased using a voucher from the Western Bookstore)