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.
|1. Recommended Prerequisite Courses|
|Human Physiology in Health and Disease||3.0||Fall Classroom||Spring Classroom|
|Medical / Clinical Terminology||0.5 CEU's||Fall Classroom||Winter Classroom||Summer Classroom|
|2. Required Courses|
|Clinical Statistics for Non-Statisticians||2.0||Winter Classroom||Summer Classroom|
|Clinical Trials Site Monitoring I||2.0||Fall Classroom||Spring Classroom|
|Good Clinical Practices||3.0||Winter Classroom||Spring Classroom|
|Principles of Drug Discovery and Development||4.0||Winter Classroom||Summer Classroom|
|Science of Clinical Trials Design||2.5||Winter Classroom||Summer Classroom|
|3. Required Medical Device Course (Choose one)|
|Medical Devices: Regulatory Strategies and Marketing Pathways||1.5||Winter Classroom||Summer Classroom|
|Regulation of Medical Devices and Diagnostics||3.0||Winter Classroom||Summer Classroom|
|4. Elective Courses|
|Clinical Data Management||2.0||Spring Classroom|
|Clinical Project Management||2.0||Fall Classroom||+ Spring Blended|
|Clinical Research: The Study Site Perspective||1.5||Summer Classroom|
|Contracting with Contract Research Organizations (CROs)||1.5||Summer Classroom|
|Data Privacy and Security for Healthcare and Biosciences||1.5||Fall Classroom||Spring Classroom|
|Document Preparation: Protocols, Reports, Summaries||1.5||Spring Classroom|
|Drug Safety and Adverse Events Reporting||1.5||Fall Classroom||Spring Classroom|
|Electronic Data Capture for Clinical Trials||1.0||Summer Classroom|
|Good Manufacturing Practices||3.0||Winter Classroom|
|Medical Writing||2.0||Fall Online||Spring Online|
|Preparing for FDA Inspections and Conducting Sponsor Audits||1.5||Spring Classroom|
|5. Additional Courses of Interest|
|Biology of Cancer||2.0||Fall Classroom|
|Clinical Trials Essentials: An Intensive One-Week Course||3.5||Winter Classroom|
|Viruses, Vaccines and Gene Therapy||1.5||Summer Classroom|
|6. Fee for Certificate Review|
|Clinical Trials Design and Management Certificate Completion Fee||None||Fall Online||Winter Online||Spring Online||Summer Online|
Please review the course descriptions to ensure that you have taken necessary prerequisites or meet the requirements through job experience or previous education.
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.
Recommended Course Sequence
Please follow this sequence: After completing the prerequisites, begin with Principles of Drug Discovery and Development. After that, courses may be taken in any order provided the prerequisites are met. You must take one device course—Medical Devices: Regulatory Strategies and Marketing Pathways or Regulation of Medical Devices and Diagnostics.
To receive your certificate
Upon completion of the course sequence you may request your Clinical Trials Design and Management Certificate Completion Review.
Dual Certification & Shared Credit
Learn more for Less: You can complete two bioscience certificate programs at UCSC Extension simultaneously or in sequence with fewer units than if the programs were taken individually. Students pursing two certificates need to:
- Complete the total number of units indicated in the table below.
- Complete all required courses for both programs.
- Count each unit only once.
- Select some electives that are common to both programs.
|Biotechnology||Clinical Trials||Medical Devices||Regulatory Affairs||Bioinformatics|
|Biotechnology||19 units||32 units||31 units||32 units||30 units|
|Clinical Trials||32 units||19 units||31 units||32 units||X|
|Medical Devices||31 units||31 units||17 units||31 units||X|
|Regulatory Affairs||32 units||32 units||31 units||19 units||X|
|Bioinformatics||30 units||X||X||X||16 units|
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.
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.
You can enroll in a certificate program any time during your studies.
Once you create your student account, you can enroll in a certificate program. Although you can enroll in a program at any time, the benefit of enrolling early is that it locks in your certificate requirements. This means that even if program requirements change, the requirements to complete your certificate will remain the same for you.
- You must enroll in the certificate program before enrolling in the Certificate Completion Review.
You have a total of five years to complete all necessary courses in a certificate program.
All the necessary units in a certificate must be completed within a five-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, 2017, you would have to complete all of the required units in this certificate by Sept. 4, 2022.
- 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.