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Certificate Program in Clinical Trials Design and Management
Below this overview, you will find a list of all the courses associated with this program. While not all courses are currently offered, you can view each course description to become more familiar with the complete curriculum of the certificate or award.
Certificate Contact
Applied and Natural Sciences Department, (408) 861-3860, or e-mail program@ucsc-extension.edu.
Program Overview
The Bay Area and Silicon Valley are leaders in the global biopharmaceutical and medical device industries. The continued success of these industries relies on the clinical trial--the complex process of ensuring the safety and effectiveness of new and existing medical products.
Well-planned and well-executed clinical trials are the cornerstone of effective drug and medical device development and are critical to ensuring the protection of human volunteers. Clinical trials personnel from all sectors, including academia, clinical practices, industry and government agencies, require specialized knowledge that can often be difficult to acquire and is frequently obtained only through on-the-job experience over a number of years.
The Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, from drug and device development to monitoring, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research. Because of its comprehensive curriculum and its intense focus on best practices in the clinical trials process, our certificate is appropriate for current professionals--clinical research associates and coordinators, clinical program managers and physicians, biomedical and research scientists, nurses, IRB members and administrators, and pharmacists--as well as those new to the field.
If you are pursuing the clinical research coordinator (CRC) or clinical research associate (CRA) credentials, you may be able to fulfill educational requirements by completing this program. Many courses in this program qualify for re-certification CEUs for those certified as CCRAs and CCRCs through ACRP. Most courses also grant BRN credit for nursing professionals.
Certificate Requirements
To obtain the Certificate in Clinical Trials Design and Management, you must complete six required courses and 6 units of elective courses , for a minimum total of 19 units. In order to be eligible for this certificate, you must (1) complete all course work within three years of filing the application to establish candidacy, and (2) achieve an overall 3.0 grade point average (GPA) for all required and elective courses. In addition, all courses applying toward the certificate must have been successfully completed within five years of the date on which the certificate is issued. Please refer to www.ucsc-extension.edu/gpa, for our GPA calculator. Students who complete a certificate program with a GPA of 4.0 will earn a Certificate with Honors.
Students pursuing both the Clinical Trials Design and Management and Biotechnology or Regulatory Affairs certificates need a minimum of 32 units, including all required courses and elective units for both programs. Please note that in order to complete two certificate programs with the minimum number of units, students must select some electives that are common to both programs. Please contact us at program@ucsc-extension.edu or call (408) 861-3860 if you need more information or would like assistance creating a study plan.
Courses may be taken individually or as part of the certificate program.
Prerequisites
A familiarity with medical terminology is required. Successful completion of "Medical Clinical Terminology," or an equivalent course, or equivalent experience satisfies this requirement. We strongly recommend that students without a medical background take "Human Physiology in Health and Disease" early on in their studies.
Recommended Course Sequence
We recommend that you begin the program with "Drug Development Process" (after completing the prerequisites). From that point on, courses can be taken in any sequence, unless otherwise specified.
Required Courses (Six)
- Clinical Statistics for Non-Statisticians (2 units)
- Clinical Trials Site Monitoring I (2 units)
- Drug Development Process (2 units)
- Good Clinical Practices (3 units)
- Medical Devices: Regulatory Strategies and Marketing Pathways (1.5 units)
- Science of Clinical Trials Design (2.5 units)
Elective Courses (6 units required)
- Adverse Event and Medication Coding: An Introduction to MedDRA, COSTART, and WHO-Drug (1.5 units)
- Case Report Forms Development (1 unit)
- Clinical Data Management (2 units)
- Clinical Project Management (2 units)
- Clinical Research: The Study Perspective (1.5 units)
- Clinical Trials Site Monitoring II (1.5 units)
- Contracting with Contract Research Organizations (CROs) (1.5 units)
- Development of Clinical Standard Operating Procedures (1.5 units)
- Document Preparation: Protocols, Reports, Summaries (1.5 units)
- Drug Safety and Adverse Events Reporting (1.5 units)
- Electronic Data Capture for Clinical Trials (1 unit)
- Electronic Records for Regulated Environments: Cost-Effective Approaches to Compliance (1.5 units)
- Global Conduct of Clinical Trials (1.5 units)
- Good Manufacturing Practices (3 units)
- Medical Device Design and Development (2 units)
- Medical Writing (2 units)
- Molecular Diagnostics (1.5 units)
- Preparing for FDA Inspections and Conducting Sponsor Audits (1.5 units)
- Regulation of Drugs and Biologics (3 units)
- SAS Programming for the Non-Programmer, Introduction (3 units)
- SAS Programming for Clinical Trials (3 units)
- Toxicology Basics for Biotechnology (1.5 units)
Certificate Application Information
We encourage you to establish candidacy in a certificate program early in your studies. Curriculum changes subsequent to the date your application is received will not affect your course requirements. Candidates will be notified of updates or special opportunities related to the program, priority enrollment in fully enrolled courses, and job leads from prospective employers. Certificate applications can be submitted through our online form or using our PDF form .
Once the requirements of the certificate have been met, students must contact our office at program@ucsc-extension.edu to request their certificate.
Transferring Credit From Other Schools
Subject to departmental approval, students may substitute one equivalent course from another institution for one in the certificate program. To be considered, download a "Substitution Request Form" and send your request along with a course outline and description.
ACRP Contact Hours
Many of the required and elective courses in UCSC Extension's Clinical Trials Certificate Program qualify to provide contact hours toward ACRP recertification. See the Association of Clinical Research Professionals Web site at acrpnet.org for certification information.
BRN: Board of Registered Nursing
All courses designated BRN are approved for continuing education hours for RNs and LVNs (Provider #CEP13114).
RAPS Credit
Many of the required and elective courses in UCSC Extension's Clinical Trials Certificate Program qualify for points toward recertification for RAC. See the Regulatory Affairs Professionals Society Web site at raps.org for details.
