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.


Why Choose National University?

We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 180,000 alumni worldwide.

Four-Week Classes

Focus on one subject at a time — one month at a time — and finish your degree faster.

75+ Degree Programs

Choose from associate, bachelor’s, and master’s degrees, plus credentials and certificates.

On Campus or Online

Study when and where it’s convenient for you with evening, weekend, and 100% online classes.

Year-Round Enrollment

Apply or transfer any time. Classes start monthly, and applications are accepted year round.

20+ Locations

Attend class and learn onsite at one of over 20 locations in California.

Military Friendly

As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.