Clinical Operations Part 2

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.


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 200,000 alumni worldwide.

Four-Week Courses

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

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

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

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

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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.

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