
Clinical Trials Design and Management
Building safety into innovation
"The basic philosophy of clinical trials is the same around the world: it is for the protection of human subjects participating in research."
Ramesh Aacharya, Clinical Trials Design and Management Alumnus
Program Description
Classroom • Online • Blended
For the protection of trial subjects
Learn from leaders in the global biopharmaceutical and medical device industries who are discovering new treatments and health products every day. You will gain a solid and practical understanding of the entire clinical trials process—from drug and device development to monitoring—and gain a foundation in the scientific principles, current regulations, and ethical issues involved in clinical research.
Clinical Trials Design and Management certificate program objectives
- Understand and apply Good Clinical Practices (GCP)
- Distinguish regulatory requirements and differentiate between regulations, guidelines, policies and standard operating procedures (SOP)
- Identify the roles, responsibilities, interactions and concerns of study site personnel
- Use coding dictionaries such as MedDRA® and WHO-Drug for adverse event reporting
- Prepare clinical trial reports, summaries and other documentation
- Understand clinical trials designs, management, and approval objectives for drug and device development.
- For successful interactions with clinical sites, investigators, regulators, contract research organizations, and sponsor management.
- Understand the use of statistics in designing clinical trials and analysis of results.
Total Required: 8–10 courses/19 units. Take 6 core courses (14–15.5 units), 2–4 elective credit courses (5 units). End with certificate of completion review.
Time Commitment: A full-time student can complete the certificate in 9–12 months.
Estimated Cost: $ 8,000
F1 Students: [Costs for F-1 students]
Courses
Total Required: 8–10 courses/19 units. Take 6 core courses (14–15.5 units), 2–4 elective credit courses (5 units). End with certificate of completion review.
1. Prerequisite Course
2. Recommended Prerequisite Course
3. Required Courses. Choose one Device Course.
4. Elective Courses
6. Required Certificate Review
Requisite Knowledge
Please review the course descriptions to ensure that you have taken necessary prerequisites or meet the requirements through job experience or previous education.
Prerequisites
Familiarity with medical terminology is required. You can satisfy this requirement by taking Medical/Clinical Terminology, an equivalent course, or substituting relevant work experience. We strongly recommend that students without a medical background take Human Physiology in Health and Disease early in their studies.
Recommended Course Sequence
Please follow this sequence: After completing the prerequisites, begin with Drug Development Process. After that, courses may be taken in any order provided the prerequisites are met. You must take one device course—Medical Devices: Regulatory Strategies and Marketing Pathways or Regulation of Medical Devices and Diagnostics.
Substitutions
Dual Certification & Shared Credit
Learn more for Less: You can complete two bioscience certificate programs at UCSC Extension simultaneously or in sequence with fewer units than if the programs were taken individually. Students pursing two certificates need to:
• Complete the total number of units indicated in the table below.
• Complete all required courses for both programs.
• Count each unit only once.
• Select some electives that are common to both programs.
Biotechnology |
Clinical Trials |
Medical Devices |
Regulatory Affairs |
Bioinformatics |
|
---|---|---|---|---|---|
Biotechnology |
19 units | 32 units | 31 units | 32 units | 30 units |
Clinical Trials |
32 units | 19 units | 31 units | 32 units | X |
Medical Devices |
31 units | 31 units | 17 units | 31 units | X |
Regulatory Affairs |
32 units | 32 units | 31 units | 19 units | X |
Bioinformatics |
30 units | X | X | X | 16 units |
To receive your certificate
Upon completion of the course sequence you may request your Clinical Trials Design and Management Certificate Completion Review.
Professional Development
Other professional credit. Extension courses also provide credit toward other professional programs.
- Certified Clinical Research Administrator (CCRA) recertification units
- Certified Clinical Research Coordinator (CCRC) recertification units
- Association of Clinical Research Professional (ACRP)
- California Board of Registered Nursing (BRN) continuing education units
Program Chair

EDWARD ROZHON, Ph.D., chair of the Bioinformatics, Biotechnology, and Clinical Trials Design and Management programs, has had a long career in the biopharmaceutical industry as a contributor to the development of drugs to treat viral and autoimmune diseases, as well as several types of cancer. He has worked in both nonclinical and clinical areas of drug development, in the global pharmaceutical and biotech industry, in a contract research organization to support clinical research as well as in academia. He retired from Genentech in 2014 as a senior manager of clinical trials for autoimmune, infectious, and ophthalmologic diseases. On completing his doctorate at Indiana University, he pursued post-doctoral training in neurovirology at the University of Alabama School of Medicine and at Northwestern University School of Medicine and was subsequently appointed to a faculty position in microbiology and immunology. He has taught courses in drug development and virology at UCSC Extension since 2001.
Enroll in Program
You are invited to declare candidacy in your certificate program as soon as possible so you can lock in the curriculum requirements and not be impacted by any subsequent program changes. Once you’ve declared, you have three years to complete the program.
Contact
Have a question about Clinical Trials Design and Management Certificate Program or want to subscribe for updates? Use the form below.
You may also contact our Outreach Team at (408) 861-3860 or ExtensionProgram@ucsc.edu.
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