The master’s degree in Clinical Research consists of 40 quarter units of study.
Core Courses (30 units) in Epidemiology, Patient-Oriented Research, Biostatistics, Scientific Communication Skills, Health Services Research, Data Management/Informatics, and Professional Development make up the bulk of the 40 unit degree. These are supplemented by additional advanced statistics, experiential courses, and other elective courses selected by you to complete your own personal pathway. It all culminates in a presentation of your Independent Study Research Project.
Coursework can be completed in 12, 18 or 30 months of study, depending upon a participant’s time to devote to the program. Students enter the program either in the winter (January) or summer (June) quarter. Full time students and International students may only enter the program during summer quarter.
Most required courses are conducted year-round over four consecutive 11-week periods. The academic year is comprised of four quarters: summer (June), fall (September), winter (January), and spring (April).
Classes are typically held in the late afternoons, evenings, to allow flexibility for participants’ home/work lives. The regularly scheduled core classes are typically held from 4-6pm at University City Center off I-805/Governor Drive. Elective classes are held either at University City Center or the La Jolla Campus, and their time offerings vary.
Three classes are open for public enrollment without being admitted to the master’s degree first: Translational Research Fundamentals (CLRE-236), Applied Drug Discovery and Development (CLRE-238), and Stem Cell Translation (CLRE-237). Flier (PDF)
(Contact the department for more information.)
For a more detailed description of: CLRE-236
The portfolio of course offerings for the program:
(Scroll down below tables for descriptions of courses)
Experiential Learning in Clinical Research - 2 X 2 units - CLRE-270
These experiential courses build on the knowledge gained in the core curriculum through hands-on lab and simulation-based exercises. Students will learn basic lab methods and communication skills pertinent to engaging subjects in clinical research.
ISP Seminar Series A & B - 2 X 2 units - CLRE-295 A,B
In these courses, you will be assigned a MAS mentor to discuss your career development plan, self-assessment and hone in on an independent study project (ISP). You will also be working with your MAS mentor, the ISP Data set Coordinator and the Mentor Director to determine who your research mentor will be. You will submit a ISP prospectus which will be a summary of your proposed research project and goals. The courses will consist of readings, assignments and formalized mentoring sessions as well as potentially meeting one or two research mentors. These courses should be stepping stones into the ISP course. Once your research mentor has been assigned, you will look into data sets that tie into your ISP and plan a pace of study for your project.
Epidemiology I - 2 units - CLRE-251
This course exposes you to the basic principles of epidemiology, including etiology, transmission, outbreak investigation, disease surveillance, screening, and study design. Students will learn about cross-sectional, case-control, cohort and intervention study designs, their strengths and limitations, and how to make the proper choice of study design for conducting your own research. You will learn to identify and calculate the correct measure of risk for each study design, recognize major sources of bias, confounding and misclassification, and understand design and analysis methods of dealing with each, while becoming familiar with criteria to differentiate association from causation.
Epidemiology II - 2 units - CLRE-257
This course is designed to introduce you to researchers in various epidemiological content areas, including (but not limited to) spatial, environmental/occupational, cancer, nutrition, tobacco and perinatal/reproductive epidemiology. Students will be exposed to a variety of methodologic considerations, including study design and conduct, measurement issues, bias, and data analysis and interpretation relevant to the unique exposures and outcomes in each content area. Students will gain an understanding of the application of epidemiologic methods, and will be introduced to research possibilities.
Patient-Oriented Research I - 2 units - CLRE-250
In POR I you will learn and apply the basic elements of design, implementation, and analysis of interventional research. You will develop and present a concept proposal for a clinical trial to your peers and the course faculty and submit it as a product of the course.
Patient-Oriented Research II - 2 units - CLRE-256
POR II builds on POR I by reviewing the ethical and regulatory basis for human research. You will prepare a proposal to the UCSD (institutional Review board (IRB), participate in a mock IRB meeting as both an applicant and reviewer, and submit the completed IRB proposal as the final written submission for the course.
Scientific Communication Skills - 2 units - CLRE-259
This course covers the key elements of scientific communication skills that are designed to enhance your ability to be a successful clinical researcher. Topics covered in the course include the secrets of making good oral presentations and engaging the audience, learning how to write and prepare abstracts, acquiring the basics of grant writing and submission, and gaining knowledge on how grants are reviewed. The course includes a mock grant study section.
Biostatistics I - 2 units - CLRE-253
In this course you will gain an understanding of the principles of measurement of clinical data, learn to recognize data types, and to correctly identify statistical methods appropriate for analysis of a given clinical data set. You will gain experience in assembling a clinical dataset in formats suitable for analysis by STATA or other comparable statistical packages. You will also learn skills for conducting graphical and numerical exploratory data analysis, comparative tests of categorical, ordinal, and continuous data, linear and logistic regression analysis, and survival analysis by life table and Kaplan-Meier techniques.
Biostatistics II - 2 units - CLRE-254
This course gives you the skills to understand and conduct advanced bio-statistical analyses including: multiple linear and logistic regression, survival analysis, and Cox and extended Cox regression. You will become familiar with person-time rate analysis, Poisson regression, and longitudinal data analysis in the presence of missing values and varying measurement times. This course is a pre-requisite for taking advanced stat courses. (You may take an advanced stat course simultaneously with this course.)
Health Services Research - 2 units - CLRE-252
The main goals of this course are to educate you in identifying the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety. You will learn about three major aspects of health care: the effectiveness and quality of the care, access to care, and its cost. Data sources and methods (e.g., program evaluation, qualitative research, and survey research) which are used to evaluate the effects and outcomes of the health care system on people’s health will also be introduced in the course.
Data Management/Informatics - 2 units - CLRE-255
This course will provide you with an orientation to database design and management, and covers key issues regarding data handling for clinical research and clinical trials. You will also become familiar with technology assessment and decision-making methods and analysis.
Professional Development Seminar Series - 2 units - CLRE-258
There will be four different seminars. One is required and the others can be taken toward general elective units. The series of seminars on professional development will focus on skills and knowledge to enhance your ability as a clinical researcher to be successful. Seminar topics include: research budgeting and billing, project management, group coaching and personal skills.
Independent Study Project - 2 units - CLRE-297
The Independent Study Project (ISP) is the cornerstone of the MAS program. You will be involved in a high-level clinical research project that integrates what you have learned in your formal coursework. The ISP is an independent and creative scholarly activity in an area related to one or more of the topics covered in the formal curriculum. Your work will be evaluated by a committee of faculty, and may also include industry advisors when appropriate.
Advanced Statistics Elective Courses
Analyzing Medical Data Using R - 2 units - CLRE-262
This course will introduce the R Statistical Platform and help to build proficiency for data analysis. You will perform your own analysis of the data, using linear regression methods, ANOVA, logistic regression, and regression methods for survival data. You will gain an understanding of the assumptions, areas of applicability, and limitations of these statistical methods.
Longitudinal Data Analysis - 2 units - CLRE-263
This class will introduce you to the statistical methods and techniques for analyzing medical data from longitudinal studies using PASW/SPSS software. You will gain an understanding of the challenges and statistical issues for designing and analyzing longitudinal studies, recognizing and using longitudinal data analysis methods, and performing analysis.
Clinical Decision Analysis - 2 units - CLRE-264
This course will provide you with an introduction to the use of decision sciences in health care. You will gain skills to be able to construct and evaluate an appropriate decision analysis probability tree, value health outcomes, use sensitivity analysis, and understand how to conduct a cost-effectiveness analysis.
Bioinformatics Applications to Human Disease - 4 units - MED-263
Students learn background knowledge and practical skills for investigating the biological basis for human disease. Using bioinformatics applications, they: (1) query biological and genetic sequence databases relevant to human health, (2) manipulate sequence data for alignment, recombination, selection, and phylogenetic analysis, (3) normalize microarray data and identify differentially expressed genes and biomarkers between patient groups, (4) annotate protein data and visualize protein structure, and (5) search the human genome and annotate genes relevant to human diseases.
Principles of Biomedical Informatics - 4 units - MED-264
Students will understand the main challenges of computing with phenotypes, how to integrate molecular data into electronic medical records and clinical trial records. They will get an introduction to medical decision making, consisting of introduction to decision theory, clinical decision support systems, clinical predictive models, as well as biomedical ontologies, standards, and data repositories. Students will know how to structure and query clinical data sets, and how the most commonly used privacy technologies can be used to avoid confidentiality breaches in de-identified disclosed datasets. This is a core class for the Biomedical Informatics track, and an elective for the Bioinformatics and Systems Biology track.
Advanced Regression Methods - 2 units - CLRE-265
This course will expose and familiarize you with important advanced statistical methods such as methods for numeric outcomes (Linear regression), non-linear regression, binary outcomes (Logistic regression), counts (Poisson regression), and categorical outcomes (Log-linear models.)
Translational Research Fundamentals - 2 units - CLRE-236
Students learn principles and practices of translational medicine applied to discovery and development of drugs, devices, and diagnostics. Topics covered include biomarkers, intellectual property, omics, translational imaging, pharmacogenomics-driven treatment, and discovery and development of diagnostics, stem cell therapies, and drugs.
Applied Drug Discovery and Development - 2 units - CLRE-238
Students will understand the drug discovery process through case studies in mentored teams. Each team is assigned a pharmacotherapeutic modality and will use publicly disclosed information to reconstruct the entire translational chain of events from new drug idea to market. Prerequisites: Translational Research (CLRE 236) or consent of department.
Stem Cell Translation - 2 units - CLRE-237
This course focuses on practical application of the principles of translating stem cell based therapies, especially those in early development and phase 1 studies. Students will acquire skills to translate these interventions from the bench to the bedside by designing a trial. Differences between drug development and stem cell based therapies will be highlighted.
Current Trends in Biomedical Informatics - 1 units - MED-262
Weekly talks by researchers introduce students to current research topics within BMI. Speakers are drawn from academia, health care organizations, industry, and government. This is a required course for the Biomedical Informatics track, and an elective for the Bioinformatics and Systems Biology track.
Modeling Clinical Data/Knowledge for Computation - 2 units - MED-267
This course will describe existing methods for representing and communicating biomedical knowledge. The class will describe existing health care standards and modeling principles required for implementing data standards, including biomedical ontologies, standardized terminologies and knowledge resources.
Clinical Decision Support Systems at Point of Care - 4 units - MED-269
Students learn about modeling knowledge to facilitate improved decision-making. The course includes review and discussion of case studies of specific health-related decision-support systems. Through discussions, assignments, and group projects, students learn the analytic techniques behind decision support systems as well as topics within decision-making under uncertainty, decision analysis, and evaluation of decision support systems.
CER/Comparative Effectiveness Research - 2 units - CLRE-266
CER is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions. This course will provide you with an update on CER methods and a review of the critical literature in this emerging field.
Bioethics & Medical Practice - 3 units - HLAW-216
Recent advances in medicine and biomedical research present daunting ethical challenges on a variety of fronts, including genetics, reproductive medicine, stem cell research, neuroscience, and psycho-pharmacology. This course equips legal and medical professionals with the skills to provide leadership on ethical review boards for human subjects, animal subjects, and stem cells, hospital ethics committees, and other public policy, regulatory, and oversight committees faced with increasingly complex ethical and legal decision-making.
Qualitative Research - 2 units - CLRE-232
This course provides skills in designing and carrying out a qualitative study useful for program management (planning, monitoring and evaluation) and ensuring quality in healthcare delivery. The methods included in the course are a sample of commonly used qualitative methods: structured and unstructured interviews, participatory learning methods, group and individual methods.
Occupational and Environmental Health - 2 units - FPM-246
Introduction to history/epidemiology of work-related disease. A review of occupationally-related health problems (heart disease, pneumoconiosis, peripheral neuropathy, sterility, birth defects, psychiatric disease and disability. Major modalities of prevention and control will be presented and the role of health practitioners, government, management and labor will be reviewed. Course will include guest lecturers, films, videotapes, and field visits to local industries and/or clinicians treating occupational disease.
Behavioral Science Research - 2 units - CLRE-268
The objective of this course is to provide you with instruction in contemporary methods and statistical analyses in behavioral science research. This course will teach you hands-on practical skills in developing and validating assessment measures, designing and evaluating clinical trials in behavioral sciences, dissemination and implementation methods, and translational research. By the end of the course, you should be better able to critique behavioral science research and develop research projects and grant proposals that may include behavioral aspects.
Emerging and Re-emerging Infectious Diseases - 2 or 4 units - FPM/MED-287
Designed to increase students understanding and skills required to diagnose, study, prevent, and control emerging and re-emerging infectious diseases. This course will focus on contributing factors in emergence, surveillance, epidemiology, prevention and methodology for studying these diseases. (Offered alternate fall quarters).
Cultural Perceptions about Health/Disease - 4 units - FPM-270
The US is characterized by significant ethnic and cultural diversity due to historic and ongoing immigration. The purpose of this course is to examine issues related to ethnic and cultural diversity and how culture may impact health beliefs, health status, and utilization of health services. The course examines issues faced by health providers and researchers who work with diverse populations in domestic or international settings. We will also explore the concept of cultural competence and how it may be achieved. Relevant socio-cultural theories will also be addressed. We will employ several strategies to accomplish these objectives including didactic studies, student-centered learning, and case studies. Students will prepare a final paper and present findings to colleagues and invited instructors.
Global Health Policy A - 3 units - HLAW-219A
Global health is increasingly becoming a dominant issue in discussions regarding public health, international relations, biomedical and environmental sciences, economics, social sciences, public policy, diplomacy, and law. Global health describes a phenomenon that occurs all throughout the world and invokes transnational health issues requiring multidisciplinary and global efforts to solve some of humanity’s most pressing challenges. Approaches to address these concerns require an understanding of the process of public policy integrated with the reality and specifics as to the issue, geopolitical concerns, and limits defined by local and global contexts. The resulting efforts at global health policy have origins within and outside the realm of the peoples and populations who are the focus of the policy. This course is an assessment of what global health policy is, macro and micro concerns regarding effectiveness and weaknesses, non-government perspectives, and methods of assessing success and failure in global health policy efforts.
Global Health Policy B - 3 units - HLAW-219B
Tremendous attention has been paid to specific aspects of global health policy, particularly focused upon public health approaches and models. This course will drill down to areas and intersections of different aspects of global governance and culture to assess how a spectrum of factors from politics to planning to preparedness are influenced by forces within and outside public health models and strategies. Students will develop a disaster and emergency preparedness plan to address key high level concerns to identify and accomplish public health goals using scenario role playing.
Molecular and Cellular Basis for Disease - 3 units - MED-224
Lectures on the molecular and cellular mechanisms of pathogenesis. Topics will include Alzheimer’s disease, cell surface and nuclear receptors in disease, signal transduction by oncogenes in cancer cells, AIDS, human diseases affecting glycosylation pathways, rheumatoid arthritis, and arteriosclerosis.
Drug Discovery, Development, & Commercialization - 3 units - SPSS-273
This elective is designed to increase knowledge of the drug discovery, development, regulatory, and commercialization process. Students will have an increased understanding of how an investigational agent eventually becomes an approved drug for patient use. Lectures and a student group project are conducted for this elective.
Introduction to Biomedical Natural Language Processing - 4 units - MED-277
Biomedical Natural Language Processing (BioNLP) is an essential tool in both biomedical research and clinical applications. Students taking this course will learn how to process free text data and their integration with other types of biomedical data with BioNLP.