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Clinical Trials Design and Management
Certificate Program

Clinical Trials Design and Management

Building safety into innovation

Establish Candidacy View Individual Courses

Certificate Description

Learn the entire clinical trial process

Phase I to III clinical trials

As you study with leaders in the global biopharmaceutical and medical device industries, many of whom are discovering new treatments and health products every day, you’ll gain a practical understanding of the scientific principles, current regulations, and ethical issues underlying clinical research.

You will gain an understanding of how to bring a new drug to market approval—from discovery of a potential drug molecule and evaluation in the laboratory and in clinical trials with human volunteers, to FDA oversight processes, including Good the principles of Good Clinical Practice.

Comprehensive curriculum

  • The impact of drug patents on pharmaceutical pricing for new drugs
  • The underlying science that drives clinical trial design
  • Statistical considerations and the kind of information obtained from trials
  • FDA regulations that govern clinical trials
  • Bioethics related to the treatment of human subjects participating in clinical trials
  • Basic concepts related to drug safety

Clinical Trials Design and Management certificate learning outcomes

  • Demonstrate an understanding of the mechanics and key regulatory requirements of conducting a clinical trial to evaluate the safety and efficacy of an investigational drug in human volunteers.
  • Have an awareness and rudimentary understanding of the technologies that biopharmaceutical companies employ to discover and evaluate the pharmacological activities of potential new drug molecules.
  • Know the key players involved in drug discovery and development:
    • Biopharmaceutical companies;
    • Contract research organizations; and
    • Clinical sites conducting Phase I through Phase III studies.
  • Understand the role of key oversight organizations
    • U.S. Food and Drug Administration in the context of Good Clinical Practice;
    • Relevant Title 21 Code of Federal Regulations; and
    • International Conference of Harmonization Guidelines in the conduct of clinical studies.
  • Assess how clinical trials are designed specific to different therapeutic areas.
  • Identify the role biostatistics plays in designing the clinical protocol and evaluating the resulting safety and efficacy data.

Estimated Cost (You pay only for courses you enroll in): $ 8,000 | International Tuition Cost
Required Credits: Total Required: 16 units (6–8 courses), including 11.5 core units (4 courses) and 4.5 electives (2–4 elective courses). End with certificate of completion review.
Duration: A full-time student can complete this certificate in 9–12 months.

Courses

Course Units Fall Winter Spring Summer
1. Required Course(s): Four Total & Equal to 11.5 Units
Clinical Statistics for Non-Statisticians 2.0 Winter TBD
Good Clinical Practices 3.0
Principles of Drug Discovery and Development 4.0
Science of Clinical Trials Design 2.5
2. Electives: At Least 4.5 Units
Clinical Data Management 2.0
Clinical Project Management 2.0
Clinical Research: The Study Site Perspective 1.5
Data Privacy and Security for Healthcare and Biosciences 1.5
Document Preparation: Protocols, Reports, Summaries 1.5 Spring TBD
Drug Safety and Adverse Events Reporting 1.5
Electronic Data Capture for Clinical Trials 1.0
Good Manufacturing Practices 3.0
Healthcare Equity: Improving Access 1.5
Medical Devices: Regulatory Strategies and Marketing Pathways 1.5
Medical Writing 2.0
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
3. Completion Review:
Clinical Trials Design and Management Certificate Completion Fee None
4. Related Course(s): These Courses Are Not Part of The Certificate Program
Biology of Cancer 2.0
Clinical Trials Essentials: An Intensive One-Week Course 3.5
Viruses, Vaccines and Antiviral Therapy 1.5

Certificate Inquiry Form

Contact Us
Speak to a student services representative.

Call (408) 861-3860

Envelope extension@ucsc.edu

Professional Development

Licensure and certification

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. An ACRP certification is optional to practice in the industry.

  • 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 counts toward continuing education units. Registered nurses are required by the California Code of Regulations, Section 1451, Article 5 to complete 30 contact hours of continuing education every two years, in addition to paying the renewal fee, to maintain an active license.

Regulatory Affairs

Courses in our Clinical Trials Design and Management program help prepare professionals (with three to five years in the regulatory field) for the Regulatory Affairs Certification (RAC) exam. An ACRP certification is optional to practice in the industry.

Please see our Licensure and Certification Policy to learn more.

Requisite Knowledge

Familiarity with medical terminology is required. We strongly recommend that students without a medical background take Human Physiology in Health and Disease early in their studies.

Advisory Board

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 Advisory Board

ALYSON FALWELL, M.P.H.
Clinical Research Operations Manager
Stanford Children’s Health 

AHMED HAMDY, M.D.
Head, Early Stage Clinical Development
Acerta Pharma

MICHAEL HUSTON, M.B.A., RAC
Huston Associates, LLC
Senior Director, R&D Operations, Xalud Therapeutics 

SHELDON MULLINS, M.S.B.A. 
Senior Director, Regulatory Affairs, Ardelyx Inc.
Lecturer, Medical Product Development Management (Master's Program), San Jose State University
Instructor, UCSC Extension Silicon Valley (Regulatory Affairs)

THOMAS PAMUKCU, B.S.
Founder/CEO of Health Wallet
Instructor, UCSC Extension Silicon Valley (Clinical Trials)

EDWARD ROZHON, Ph.D.
Instructor and Chair Biotechnology and Clinical Trials Design and Management programs
UCSC Extension Silicon Valley

NARINDER SINGH, PharmD, M.B.A. 
Director of Pharmacy, Santa Clara Valley Medical Center. 
Instructor, UCSC Extension Silicon Valley (Clinical Trials and Regulatory Affairs)

Establish Candidacy

Establish candidacy in a certificate or specialization

Once you create your student account, you can establish candidacy in a certificate or specialization program any time during your studies.

The benefits of enrolling early
  • Lock in your certificate requirements.This means that even if program requirements change, the requirements to complete your certificate will remain the same for you
  • Receive program updates
  • Set your intention
  • It’s free

To complete a program, you must enroll in the certificate program before enrolling in the Certificate Completion Review.

You have five years to complete all necessary courses in a certificate program or three years to finish up a specialization program.

All the necessary units in a certificate must be completed within this window.* The clock begins on the first day of your first course in the certificate program. For example, if you started a course on Sept. 5, 2017, you would have to complete all of the required units in this certificate by Sept. 4, 2022.

Note:

Enrolling in a certificate program does not trigger the beginning of the five-year window. It begins the first day of the first course that applies to a certificate program. The Certificate Completion Review process does not have to occur within the five-year timeframe.

For more information: How do I get my certificate or specialization?

* Students participating in a special program, such as workforce, international, Personal Financial Planning, or curriculum partner programs (Udacity, Microfacturing Institutes) may have a shorter completion requirement.

Establish Candidacy

Grade Requirements

Please note that only letter grades of C- or higher may be applied to a certificate, and in some programs, students may have more stringent requirements. Students in most employer- and government-sponsored payment programs, such as workforce development, as well as international students on F-1 visas, need to maintain a B average to meet their requirements. Personal Financial Planning students have additional grade requirements for individual courses to attain a certificate.

See Grading and Credits Policy for further information.