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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
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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.

Program Overview

Estimated Cost: Starting at $4,680. (You pay only for courses you enroll in.) | International Tuition Cost
Program Requirements: 6–7 courses (minimum 16 quarter units). Take 4 courses (11.5 quarter core units) and 2–4 elective courses (minimum 4.5 quarter units). End with certificate of completion review.
Minimum Hours of Instruction: Minimum 160 hours of instruction.
Estimated Duration: A full-time student can complete this certificate in 9–12 months.
Special Programs:
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Course Quarter Units Fall Winter Spring Summer
1. Required Course(s): Four Total & Equal to 11.5 Units
Clinical Statistics for Non-Statisticians 2.0 Summer Flexible
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
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 Spring TBD
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
Viruses, Vaccines and Antiviral Therapy 1.5

Meet Our Instructors

Aditi Sapre
Director of Biostatistics, Organon
Amanda Whalen
Senior Data Sciences Product Leader, Genentech
Clarisa A Tate
Director of Regulatory Affairs, USA & Canada, Ypsomed USA
No image for David A West
Senior Director of Medical Writing, Gilead Sciences
No image for Don  Young
Consultant in Clinical Biostatistics
Edward James Rozhon
Program Chair | Retired Sr. Manager, Clinical Operations, Genentech
Gerald  P Shabe
President, Advance Research Associates
Jeaneen C Wallis
Consultant | Instructor
Karim N Sajwani
Executive Director Clinical Operations at Telios Pharma
Narinder Singh
Pharmacy Director, Santa Clara Valley Medical Center
Romi Behbehanian
Sr. Director | Global Scientific Program Director. | BPharm tech
Sreenivasan Paruthiyil
Research Scientist, UCSF Medical Center
Thomas  R Pamukcu
CEO, Health Wallet

What students are saying

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)

ACRP-CP Certification Eligibility Requirements

  • To be eligible for the ACRP-CP certification exam, applicants must attest to having earned 3,000 hours of professional experience performing the knowledge and tasks located in the six content areas of the ACRP-CP Detailed Content Outline. Visit the ACRP-CP certification page for more information.
  • ACRP only accepts clinical research degrees. Certificate programs are excluded from the eligibility requirements. The change was made to their eligibility criteria in 2019 and was phased out officially in 2021.

California Board of Registered Nursing (BRN)

California Board of Registered Nursing logo

UCSC Silicon Valley Extension is a California Board of Registered Nursing Continuing Education Provider (License #13114).

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

Clinical Research Operations Manager
Stanford Children’s Health 

Head, Early Stage Clinical Development
Acerta Pharma

Huston Associates, LLC
Senior Director, R&D Operations, Xalud Therapeutics 

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)

Founder/CEO of Health Wallet
Instructor, UCSC Extension Silicon Valley (Clinical Trials)

Instructor and Chair Biotechnology and Clinical Trials Design and Management programs
UCSC Extension Silicon Valley

Director of Pharmacy, Santa Clara Valley Medical Center. 
Instructor, UCSC Extension Silicon Valley (Clinical Trials and Regulatory Affairs)

Establish Candidacy

Who should establish candidacy?

  • People who are pursuing a certificate (and have enrolled in a course in the program).
  • People who want to lock in the current requirements of a certificate or specialization.
4 Simple Steps to a Certificate or Specialization
  1. Complete a course in your selected program.
  2. Establish candidacy. Click on the Establish Candidacy button on your program page.
  3. Take all required courses for certificate completion.
  4. Once your grades are posted on your final course, enroll in the certificate review fee.
A Benefit of Establishing Candidacy

Program requirements may change. Once you commit to a program by establish your candidacy, you will not have to change your plans to meet new requirements. They are locked in for you. Timeline: 4 years to get it done (or 3 for a specialization) You must complete all the necessary units in a certificate within a four-year 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, 2023, you would have to finish by Sept. 4, 2027.

Note: Establishing candidacy does not trigger the beginning of the four-year window. It begins the first day of the first course in your chosen certificate program. The Certificate Completion Review process does not have to occur within the four-year timeframe.

Exceptions to the four-year requirement
  • If you Established candidacy prior to Jan. 1, 2024, you will have five years to complete a program.
  • Students participating in a special program, such as workforce, international, or our curriculum partner programs, such as the Legal Studies courses (CLS by Barbri) and sales and business courses (Ziplines Education) have shorter completion requirements.

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.