CREST Curriculum and Course Descriptions
CREST (Clinical Research Enhancement through Supplemental Training) program is targeted to researchers from all disciplines, particularly physicians enrolled in fellowship training or starting their academic career. The curriculum provides comprehensive coverage of all dimensions of clinical research while allowing scholars to spend the majority of their time in research and clinical activities.
Total units required for CREST Certificate: 20
Please note that "Core Courses" are offered twice a year but you only need to take them once.
CLRE-251: Epidemiology I -Winter or Summer - 2 units
Epidemiology I: Balambal Bharti, MBBS, MPH, PhD and John Bellettiere, PhD
Objectives: Scholars will recognize and understand different types of epidemiologic study designs, the relative strengths and limitations of each, and the proper choice of study design in conducting their own research. They will also be able to identify and calculate the correct measure of risk for each study design. Participants will recognize major sources of bias, confounding, interaction and misclassification, and understand design and analysis methods of dealing with each. They will also be familiar with criteria to differentiate association from causation, and understand the components of causality. Participants will conclude this course with a written final examination.
Course Content
| Topic | Content |
|---|---|
|
Introduction |
Disease transmission, population based investigation |
|
Epidemiological Measurement |
Rates, adjusted rates, prevalence, incidence |
|
Cross-Sectional Studies |
Design, implementation and analysis |
|
Prospective/Cohort Studies |
Design, implementation and analysis |
|
Case Control Studies |
Design, implementation and analysis |
|
Intervention Studies/Experimental |
Design, implementation and analysis |
|
Bias, Confounding and Interaction |
How to recognize, avoid, or correct |
|
Screening and Diagnostic Testing |
Sensitivity, specificity, screening programs |
|
Causality |
Association vs. Causality, components of causality |
|
Review for Final Exam |
CLRE257- Epidemiology II - Spring or Fall - 2 units
Epidemiology II: Balambal Bharti, MBBS, MPH, PhD and John Bellettiere, PhD
Objective: Scholars will build on the content of Epidemiology I by attending guest lectures given by epidemiologists currently active in their field. Both methodology and content will be addressed in these guest lectures including topics such as smoking studies, genetic epidemiology, reproductive epidemiology, ecological studies, and the epidemiology of violence. Students will also gain an understanding of health disparities in epidemiologic research and be exposed to additional and advanced epidemiologic methods such as meta-analysis and cluster analysis. Participants will become familiar with advanced epidemiological issues and understand how study designs are practically applied in specific content areas. Students conclude this course with written exam.
Course Content
| Topic | Content |
|---|---|
|
Epidemiology I Review |
Review basic epidemiologic concepts |
|
Smoking Studies |
Study design, outcomes, controversies |
|
Ecological Studies |
Current topics and examples of this study design |
|
Health Disparities |
How health disparities are defined and measured in epidemiologic studies |
|
Epidemiology of Violence |
How epidemiology is applied to the study of violence and public health |
|
Reproductive Epidemiology |
Current studies in reproductive epidemiology |
|
Genetic Epidemiology I |
Basic concepts |
|
Genetic Epidemiology II |
Advanced concepts |
|
Advanced Methods |
Meta-analysis, cluster analysis or others |
|
Final Proposal Review |
Final proposals are reviewed by faculty and peers. |
CLRE250: Patient Oriented Research I - Summer or Winter - 2 units
Patient Oriented Research I: Sheldon Morris, MD, MPH
Objectives: This course will develop and apply the theory of clinical trial design and analysis, discuss the practical issues of financing and implementation of clinical trials, and describe issues of monitoring trials and working in cooperative groups. The scholar will design and present to a group of peers a concept sheet for a phase I/II and phase II/III clinical trial.
Course Content:
| Topic | Content |
|---|---|
|
Hypothesis Generation and Formulation |
Framework, Types, and Characteristics of Good Research Questions and formulating a testable hypothesis |
|
Introduction to POR |
Definition of POR; Origins & Scientific Basis; Causality; Validity of Inference; Classification of Clinical Research |
| Measurement | Objectives, classes, and characteristics of measures in POR and their validity, accuracy, and precision |
|
Fundamentals of Clinical Trials |
Study Objectives, Target Populations, Comparison Groups, Blinds, Outcomes and Endpoints |
|
Overview of the Process of Drug and Device Development |
Preclinical and clinical development of drugs from an industrial prospective |
|
Statistical Issues in Clinical Trials |
Sample Size/ Power Analysis; Randomization Procedures; Analytic Strategies - Sequential, Interval and Terminal; Analysis Plan |
|
Selecting and Measuring Outcomes and Study Implementation I |
Outcomes: Selecting outcomes: who gets counted, clinical vs surrogates, and simple vs compound. Implementation: Defining, recruiting, consenting, initially assessing, tracking, and retaining participants; IRB submission. |
| Study Implementation II | Assessing Adherence; Study Start-up Study Monitoring for adverse events and interacting with the IRB; Completing the study, DSMB review |
| Complex Trial Design | Multi-centered studies, Crossover and Factorial Designs, equivalence vs superiority trials, and testing diagnostics |
CLRE 256: Patient Oriented Research II - Fall or Spring - 2 units
Patient Oriented Research II: Sheldon Morris, MD, MPH
Objectives: This course will review the ethics and basic regulatory issues for research involving human subjects; the principles of data management for clinical research, including architecture, access and confidentiality, and integrity of databases; and skills in graphic and verbal presentation of research data. Scholars will prepare a mock submission to the IRB for peer review and practice presenting graphic and tabular data.
Course Content:
| Topic | Content |
|---|---|
|
Foundations of Research Regulation |
Overview of the regulation of human experimentation; Structure and Function of IRBs |
| Writing and reviewing an IRB Proposal (monitoring boards) |
Principles of IRB review |
| Monitoring of Research | Composition and functions of Data and Safety Monitoring Boards (DSMB) |
| Ethical Basis of protection of research subjects | Ethical principles for protection of human research subjects |
| Research Ethics - Responsible conduct | Conflict of interest and commitment, scientific integrity, misconduct, ethics of publishing |
| Business ethics, research budgeting, and contracts | Preparing and managing a research budget |
| Selected topics in the ethics of patient oriented research | Discussion by students of their personal case studies in ethics |
| Peer Critique of Student IRB submissions I (Simulated IRB review panel) |
Discussion of student IRB proposals by peer reviewers |
| Legal Aspects of informed Consent | Introduction to legal issues related to informed consent |
| Peer Critique of Student IRB submissions II (Simulated IRB review panel) | Discussion of student IRB proposals by peer reviewers |
CLRE253: Biostatistics I - Winter or Summer - 2 units
Biostatistics I : Florin Vaida, Ph.D.
Objectives: the students will develop and acquire the insight, tools and skills needed to be educated users and consumers of biostatistics. They will recognize data types, and correctly identify the statistical methods appropriate for analysis of a given clinical dataset. They will understand the basic concepts of statistics, including elementary probability theory, sampling, estimation, confidence intervals, and hypothesis testing. They will be able to conduct graphical and numerical exploratory data analysis using SPSS, and to perform statistical analyses, including comparative tests of categorical and continuous data.
Course Content
| Topic | Content |
|---|---|
|
Data summaries |
Numeric and graphic data summaries in SPSS |
|
Probability and normal distribution |
Elementary probability theory; the normal distribution |
|
Central limit theorem and confidence intervals |
Sampling distributions and applications to statistical inference |
|
Hypothesis testing for one group |
Hypothesis testing: type I and II error, 1-sided and 2-sided tests; t-test for one group |
|
Statistical inference for two groups |
Paired and independent groups t-test; Wilcoxon rank-sum test; sample size calculation |
|
Inference for proportions |
Binomial distribution; one-sample z-test for proportions; McNemar’s test for paired samples |
|
Inference for proportions, two groups |
Comparing proportions in independent groups: z-test, Chi-square test, Fisher’s exact test. |
|
One-way ANOVA |
One-way analysis of variance; F-test; adjusting for multiple post-hoc comparisons |
|
Two-way ANOVA
|
Additive and factorial two-way ANOVA; model selection |
CLRE254: Biostatistics II - Spring or Fall - 2 units
Biostatistics II : Florin Vaida, Ph.D.
Objectives: the students will conduct more advanced regression-based statistical analyses, including: simple linear regression and correlation analysis; multiple linear regression; logistic regression; Cox proportional hazards models. Issues of model diagnostics and analysis of residuals, model comparison and model building, and strategies for univariable and multivariable analyses will be discussed. The analyses will be conducted in SPSS.
Course Content
|
Topic |
Content |
|---|---|
|
Correlation and simple linear |
Correlation and simple linear regression |
|
Inference for simple linear |
Model formulation and estimation in simple linear regression; examination of residuals and model assumptions; prediction and explained variation |
|
Multiple Linear Regression |
multiple linear regression: model assumptions and interpretation; diagnostics; |
|
Model building |
model comparison and model building in multiple linear regression; polynomial regression; ANCOVA and ANOVA as multiple linear regression |
|
Regression for proportions |
Logistic regression for binary outcomes; model interpretation; comparing several groups |
|
Logistic regression |
Multiple logistic regression; model building and model comparison |
|
Survival analysis |
Kaplan-Meier curves and log-rank test |
|
Cox proportional hazards |
Regression methods for survival data: Cox proportional hazards model |
CLRE252: Health Services Research - Summer or Winter - 2 units
Health Services Research: Raphael Cuomo, PhD., MPH
Objective: The main goals of health services research Are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety. Students will learn about three major aspects of health care, including 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) used to evaluate the effects and outcomes of the health care system on people’s health will also be introduced in the course.
Course Content:
| Topic | Content |
|---|---|
| Orientation & Introduction HSR Definition & Conceptual Models |
Overview; Definitions; HSR models Examples of HSR |
|
Effectiveness of Care |
Effectiveness of health service |
| Access to Care | Supply of health service; Affordability; Physical accessibility Acceptability - social or cultural |
|
Quality and Clinical Guidelines |
Level of evidence/ strength of recommendation Practice guidelines Quality Improvement/ Quality Assurance Safety research; safety goals |
|
Cost Health Economics (Efficiency) |
Types of costs |
| HSR Data Sources and Data Collection | Review different data sources and data collection methods |
| Quality of Life Measurement | Quality of life instruments; Patient preferences Measuring QOL |
| Survey Research | Types of survey questions; Developing surveys Measurement principles |
| Qualitative Research | Principles of qualitative research How to conduct interviews or focus groups |
| Program Evaluation |
Evaluating health programs / systems |
CLRE255: Data Management & Informatics - Fall or Spring - 2 units
Data Management & Informatics: Mike Hogarth, M.D.
Course Descriptions: This course will provide you with an orientation to information management, and covers key issues regarding data acquisition, storage, data interoperability to support clinical research and clinical trials. You will also become familiar with technology used to capture, store, and display/analyze clinical trial data.
Course Topics
- Introduction to Clinical Research Concepts
- Emerging Trends in Clinical Research
- Master Data Management
- Security Principles, Audit, and Records Management Regulations (FISMA, NIST, FDA 21CFRPart 11, HIPAA)
- Clinical Research Information Systems
- Electronic Health Record Systems and Clinical Research
- Electronic Data Capture in Clinical Research
- Overview of the REDCap electronic data capture system
- Principles of Data Representation and Harmonization
- Narrative Text and Natural Language Processing (NLP)
- Data Storage – Database types, Relational Databases 101, SQL, NoSQL Databases, Map-Reduce computation
- Applied Lab 1: Using an RDBMS to query MIMIC3
- Cloud Computing 101, Containerization, Specialized services (Elastic MR, SageMaker ML, Alexa)
- Applied Lab 2: Using Map-Reduce to analyze large data sets (CMS dataset)
- Clinical Data Repositories, Registries, Population Health Analytics
- pSCANNER: A Case Study of a Federated Clinical Research Data Network
- Wearables, Sensors, and Remote Patient Based Data Collection and Clinical Research
- The Evolving Clinical Care Landscape: Implications for Clinical Research Informatics
CLRE259: Scientific Communication Skills - Winter - 2 units
Scientific Communication: Hemal H. Patel, PhD
Objectives: Scholars will learn the fundamentals of clear scientific writing and oral presentation of scientific work. They will also learn how to write an NIH-style grant including all components of a grant.
Course Content
| Topic | Content |
|---|---|
|
Overview |
General principles of scientific writing and oral presentation |
|
Scientific Writing |
Specific examples of good and bad writing; in-depth discussion of all parts of a scientific paper; scholars will be expected to write an abstract which will be reviewed in class. |
|
Presentation Skills |
Instruction in how to give oral presentations and how to prepare posters; scholars will give a 10-15 minute presentation to the class. |
|
Grant writing -A |
Scholars will learn how to write a KO8 or K23 type NIH grant with detailed instruction in all parts of a grant. Scholars will write a grant which will be reviewed by the instructor. |
|
Grant writing -B |
Scholars will review a grant and will participate in a mock study section led by a faculty member. |
CLRE258: Clinical Research Project Management and Budgeting (Elective)
Clinical Research Project Management and Budgeting (CLRE-258): Andrew Sarkin, PhD & Jennifer J. Ford, MBA
Professional Development Seminar (CLRE-258): Clinical Research Project Management and Budgeting:
Student will learn basic project management skills for medical research projects. Research Project Management is the application of knowledge, skills and techniques to execute research projects effectively and efficiently. It’s a strategic competency for organizations, enabling them to tie project results to research and development goals — and thus, better compete in their markets or increase their ability to get and maintain research funding. Topics include Good Clinical Practice, planning and managing resources, monitoring progress, managing risk, engaging stakeholders, tools for project management, setting and meeting goals, quality monitoring, multi site studies, and maximizing the chances of successfully carrying out clinical and health research studies. In the Research Budgeting portion of the class, scholars will gain a solid understanding of Study Set Up and Management, Effective Study Budget Preparation and Negotiation, Billing and Financial Management, Auditing, Research Compliance and Ethical Considerations.
CLRE258: Effective Communication (Elective)
Effective Communication (CLRE-258): Anne Liljenstrand, Ph.D.
Professional Development (CLRE-258): Effective Communication
The clinical research scientist's professional skills impact his or her ability to communicate, lead, influence, make decisions, collaborate, provide feedback, and manage conflict. The objective is to strengthen one's workplace 'soft skills' through self-awareness, new knowledge, and skill practice. The Myers-Briggs Type Indicator will serve as a baseline for understanding communication styles and what may limit our effectiveness. Each session builds in complexity and requires professional goal setting.
Summer Course
Introduction to clinical research - Summer Course: Bernice Ruo, MD, MAS, FACP
Link to the Application:
The UCSD Clinical and Translational Research Institute's CREST program is offering a SUMMER ONLY Course: "Introduction to Clinical Research". This course will be held once a week on Wednesday afternoons from 3-5pm at UCSD Extension: University City Center (UCC) starting July 10 to August 21, 2019.
The course will be offered as a non-credit course. Tuition for UCSD Residents, Fellows, Faculty and Medical Students will be covered by CTRI-CREST.
Course description:
This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any research that has individual human beings or groups of human beings as its unit of observation).
Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research. This is primarily accomplished by instructing students in the creation of a research protocol that is intended to address a relevant research question in their specific area of interest.
Course organization: 1 hour interactive lecture followed by 1 hour of small group discussion weekly for 7 weeks
Course goals: To introduce the process of clinical research so that students understand the concept and
vocabulary to design and interpret clinical research. To enable students to design a study to answer a
clinical research questions. To allow students to practice creating a research protocol of their own to
address a relevant research question in their specific area of interest.
Course objectives:
The objectives for this course are for participants to:
- Acquire skills for designing and interpreting clinical research
- Produce a 5 page clinical research protocol, including background, sampling, measurements, and data analysis
Prerequisites:
- Possession of at least an undergraduate degree
- An idea for a research question in clinical research that preferably has been discussed with an experienced investigator or research mentor.
- Proficiency with word processing software, biomedical literature searching with Pubmed, and reference management software (Endnote, RefWorks or other software).
- Application Deadline:
The application deadline extended to July 5th , 2019
- Fee Schedule:
UCSD Residents, Post Doctorial Fellow, Fellow (including laboratory-based fellows) and Faculty, pays $0 + textbook.
Non-UCSD Employee pays $500 + text book.