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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


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


Association vs. Causality, components of causality

Review for Final Exam

Epi I Syllabus 2022

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
Introduction to the IRB:

Overview of the regulation of human experimentation; Structure and Function of IRBs

Writing and reviewing an IRB Proposal
(monitoring boards)

Principles of IRB review
Preparation and review of applications to the IRB

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 

2022 Syllabus

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



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

2022 Syllabus

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
Comparative effectiveness
Practice variation

Access to Care Supply of health service; Affordability; Physical accessibility
Acceptability - social or cultural

Quality and Clinical Guidelines
Patient Safety

Level of evidence/ strength of recommendation
Practice guidelines
Quality Improvement/ Quality Assurance
Safety research; safety goals


Health Economics (Efficiency)

Types of costs
Costs vs. charges
Incremental & marginal costs
Types of analyses with various perspectives

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


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.

Syllabus 2022

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


  • 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). 

Link to the Application

  • 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.