Clinical Trials Design and Management
Certificate Program

Clinical Trials Design and Management

Building safety into innovation
Enroll in Certificate Program View Individual Courses
Ramesh Aacharya, Clinical Trials Design and Management Alumnus

"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

Units: 0.7 CEU CTDM.X800
Fall Classroom
Winter Classroom

2. Recommended Prerequisite Course

Winter Classroom

3. Required Courses. Choose one Device Course.

Winter Classroom
Summer Classroom
Fall Classroom
Spring Classroom
Units: 3.0 BTEC.X401
Fall Classroom
Winter Classroom
Spring Classroom
Units: 3.0 CTDM.X411
Fall Classroom
Spring Classroom
Winter Classroom
Summer Classroom
Winter Classroom
Summer Classroom
Winter Classroom
Summer Classroom

4. Elective Courses

Units: 2.0 CTDM.X400
Spring Classroom
Units: 2.0 CTDM.X401
Fall Classroom
Summer Classroom
Spring Classroom
Summer Classroom
Spring Classroom
Fall Classroom
Spring Classroom
Summer Classroom
Units: 3.0 REGL.X400
Winter Classroom
Summer Classroom
Units: 2.0 CTDM.X413
Fall + Classroom and Online (Blended)
Summer + Classroom and Online (Blended)

6. Required Certificate Review

Fall Online
Winter Online
Spring Online
Summer Online

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.

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.

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

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.

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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