Clinical Operations Part 1

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 1 covers all requirements and activities through clinical trial initiation.

Learning Outcomes

• Compare the key components in Good Clinical Practices, including responsibilities of investigators and sponsors.
• Support the key components of preparation for the conduct of clinical trials.
• Evaluate the activities involved in all operational aspects of the conduct of clinical trials.
• Appraise the requirements for, and activities involved in, the close-out of a completed (or terminated) clinical trial.
• Argue the regulatory foundations for all components of the clinical operation process.
• Contrast this clinical operation knowledge to real-life biomedical product development environments.

Prerequisites

Recommended: Prior completion of

• CAF600