Clinical Trials Design and Management
Building safety into innovation
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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.
Courses
1. Required Course(s): Four Total & Equal to 11.5 Units
2. Electives: At Least 4.5 Units
3. Completion Review:
4. Related Course(s): These Courses Are Not Part of The Certificate Program
Meet Our Instructors
Certificate Inquiry Form
Recommended Course Sequence
Please begin with Principles of Drug Discovery and Development. After that, courses may be taken in any order provided the prerequisites for those courses are satisfied. You can learn more about each course in the Syllabus Library.
Substitutions
To receive your certificate
Upon completion of the course sequence you may request your Clinical Trials Design and Management Certificate Completion Review.
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)
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 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 (such as GreenFig or CLS by Barbri) may have a shorter completion requirement.
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.