National University




CAF651 Clinical Operations Part 2

Lead Faculty: Mr. Irvin Kluth

Course Description

This course provides the student with an in-depth foundation for all operational aspects in the process of clinical research. The focus will be on developing, executing, and completing a single clinical trial. There will be detailed exploration of all aspects of the responsibilities of investigators and sponsors and the key operational aspects involved in setting up, running, monitoring, and completing a clinical trial. This Part 2 covers all requirements and activities from clinical trial start through trial close-out and archiving.

Learning Outcomes

  • Examine the key components in Good Clinical Practices, including responsibilities of investigators and sponsors.
  • Defend the key components of preparation for the conduct of clinical trials.
  • Judge the activities involved in all operational aspects of the conduct of clinical trials.
  • Evaluate the requirements for, and activities involved in, close-out of a completed (or terminated) clinical trial.
  • Appraise the regulatory foundations for all components of the clinical operation process.
  • Formulate clinical operation knowledge into a real-life biomedical product development project.

Prerequisite