This course provides the CAF student with a broad overview of clinical research as applied to the development of biotechnology, pharmaceutical and medical device products. Clinical research will be considered within the corporate, legal, and regulatory environments within which the industry operates. The course will consider key issues concerning the design and execution of successful clinical development programs.
- Use the key components in the regulatory affairs and clinical development life cycles and interpret their relationship.
- Distinguish the value of the product label as a guide to development.
- Examine the basics of Good Clinical Practice.
- Judge the structure and content of a Clinical Trial Protocol and an Investigator Brochure.
- Support the regulatory and ethical basis for the protection of human subjects and clinical trial safety monitoring.
- Evaluate the key components of clinical trial management, including site selection and management, contracts and budgets, and clinical trial monitoring.
- Design the general process for data collection and processing including development of case report forms, data management strategy, and statistical analysis plans.
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 175,000 alumni worldwide.
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.
Apply or transfer any time. Classes start monthly, and applications are accepted year round.
20+ Campus Locations
Attend class onsite at one of over 20 campus locations across California or in Nevada.
As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.