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]

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.

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

You may take one elective outside the certificate curriculum, if you receive prior approval from the Academic Services Department.

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.

To receive your certificate 

Upon completion of the course sequence you may request your Clinical Trials Design and Management Certificate Completion Review.

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

Enroll Now

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.

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