Clinical Trials Design and Management
Certificate Program

Clinical Trials Design and Management

Building safety into innovation

Enroll in Certificate View Individual Courses

Certificate Description

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.

Cost: $ 8,000 | International Tuition Cost
Required Credits: Total Required: 8–10 courses/19 units. Take 6 core courses (15–16.5 units), and 2–4 elective credit courses (4 units). End with certificate of completion review.
Duration: A full-time student can complete this specialization in 6–9 months.

Courses

Course Units Fall Winter Spring Summer
1. Recommended Prerequisite Courses
Human Physiology in Health and Disease 3.0
Medical / Clinical Terminology 0.5 CEU's
2. Required Courses
Clinical Statistics for Non-Statisticians 2.0
Clinical Trials Site Monitoring I 2.0
Good Clinical Practices 3.0
Principles of Drug Discovery and Development 4.0
Science of Clinical Trials Design 2.5
3. Required Medical Device Course (Choose one)
Medical Devices: Regulatory Strategies and Marketing Pathways 1.5
Regulation of Medical Devices and Diagnostics 3.0
4. Elective Courses
Clinical Data Management 2.0
Clinical Project Management 2.0 +
Clinical Research: The Study Site Perspective 1.5
Contracting with Contract Research Organizations (CROs) 1.5
Data Privacy and Security for Healthcare and Biosciences 1.5
Document Preparation: Protocols, Reports, Summaries 1.5
Drug Safety and Adverse Events Reporting 1.5
Electronic Data Capture for Clinical Trials 1.0
Good Manufacturing Practices 3.0
Medical Writing 2.0
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
5. Additional Courses of Interest
Biology of Cancer 2.0
Clinical Trials Essentials: An Intensive One-Week Course 3.5
Viruses, Vaccines and Gene Therapy 1.5
6. Fee for Certificate Review
Clinical Trials Design and Management Certificate Completion Fee None

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

Extension courses also provide credit toward other professional programs.

Association of Clinical Research Professional (ACRP)

Completion of the Clinical Trials Design and Management certificate program counts as 1,500 hours toward an ACRP certificate.

  • Certified Clinical Research Administrator (CCRA) recertification units
  • Certified Clinical Research Coordinator (CCRC) recertification units

California Board of Registered Nursing (BRN)

Completion of courses in this certificate program often count toward 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 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.

Certificate Inquiry Form

Contact Us
Speak to a student services representative.

Call (408) 861-3860

Envelope extension@ucsc.edu

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