Course Descriptions

CRP 241 Introduction to Statistical Methods
This course is an introduction to the fundamental concepts in statistics and their use in clinical research. Through class lectures, in class demonstrations, directed in class exercises and discussion of representative research reports from peer-reviewed journals, students are introduced to the core concepts in statistics, including: composition of data sets, descriptive statistics, hypothesis formulation, statistical significance, confidence intervals, statistical power, common statistical tests and basic statistical models. Basic statistical computations and introductory data analysis will be performed using R, a multi-platform (Windows, UNIX, Mac OS), free software environment for statistical computing and graphics. Prerequisite: None. Credit: 4. (Degree Requirement)
 
CRP 242 Principles of Clinical Research
The emphasis is on general principles and issues in clinical research design. These are explored through the formulation of the research objective and the research hypothesis and the specification of the study population, the experimental unit, and the response variable(s). The course provides a basis for understanding the classification of studies as experimental or observational, prospective or retrospective, case-control, cross-sectional or cohort; this includes the relative advantages and limitations and the statistical methods used in analysis of each type.  Emphasis is placed on the traditional topics of clinical epidemiology such as disease etiology, causation, natural history, diagnostic testing and the evaluation of treatment efficacy. Corequisite: CRP 241. Credit: 4. (Degree Requirement)
 
CRP 243 Introduction to Medical Genetics
Coverage is provided of the fundamental knowledge in human genetics and genetic systems of the mouse and other model organisms. Topics include: introduction to concepts of inheritance (DNA, chromatin, genes, chromosomes); the human genome (normal genetic variation, SNPs, comparative genomes, molecular mechanisms behind inheritance patterns, and mitochondrial genetics); mouse genetics (classical mouse genetics, genotype- and phenotype-driven approaches, QTL mapping); microarrays (expression, genomic, ChIP (chromatin IP on chip), bioinformatics and use of genome databases); genetic association studies (haplotype blocks, study design in complex disease and approaches to complex disease gene identification, pharmacogenetics and pharmacogenomics).  Prerequisite: None. Credit: 2.
 
CRP 245 Statistical Analysis
This course extends CRP 241 (Introduction to Statistical Methods) which primarily considers statistical models with a single predictor, to models containing multiple predictors.  We cover models with continuous outcomes (regression, analysis of variance, analysis of covariance), dichotomous outcomes (logistic regression), and time to event outcomes (survival models).  Prerequisite: CRP 241. Credit: 4. (Degree Requirement)
 
CRP 247 Clinical Research Seminar
This seminar integrates and builds on the core courses (CRP 241, 242, 245) to provide practical experience in the development and critique of the methodological aspects of clinical research protocols and the clinical research literature. Assigned readings are drawn from contemporary literature and include both exemplary and flawed studies.  Prerequisites: CRP 242 and CRP 245. Credit: 2.
 
CRP 248 Clinical Trials
Fundamental concepts in the design and analysis of clinical trials are examined. Topics include protocol management, sample size calculations, determination of study duration, randomization procedures, multiple endpoints, study monitoring, and early termination. Prerequisite: CRP 245. Credit: 2.
 
CRP 249 Health Services Research
Research methods in health services research are explored. Topics include measurement of health-related quality of life, case mix and comorbidity, quality of health care and analysis of variations in health care practice. Advantages and disadvantages of studies that use large databases as well as advanced methods in analysis and interpretation of health services outcomes are addressed. This includes application of traditional research designs (e.g., randomized trials) to address health services research questions and the interface between health services research and health policy. Prerequisite: None  Credit: 2.
 
CRP 253 Research Ethics and Responsible Conduct of Research
This course explores a variety of ethical and related issues that arise in the conduct of medical research. Topics include human subjects and medical research, informed consent, ethics of research design, confidentiality, diversity in medical research, international research, relationships with industry, publication and authorship, conflict of interest, scientific integrity and misconduct, intellectual property and technology transfer, and social and ethical implications of genetic technologies and research.  This course is designed to meet and exceed the NIH requirement for training in Responsible Conduct of Research.  Prerequisite: None. Credit: 2. (Degree Requirement)
 
CRP 254 Research Management
This course addresses operational issues that arise in the conduct of a clinical research project. Topics include administration (human resources, project management, budget development and management), data management systems (databases, case report forms, data acquisition, quality assurance and quality control [QA/QC], monitoring and auditing), regulation (Investigational New Drug [IND]) applications, good clinical practice [GCP], and the Health Insurance Portability and Accountability Act [HIPAA]), and sponsorship (sources, sponsor motivations, identification of sponsors). Prerequisite: CRP 242. Credit: 2. (Degree Requirement)
 
CRP 257 Proteomics and Protein Biology in Medicine
Platform technologies and computational methodologies for protein profiling and interaction analysis are introduced. The platform technologies covered include mass spectroscopy, 2D gel electrophoresis, surface plasmon resonance, protein arrays and flow cytometry. Structural biology and high-throughput screening methods are also discussed.  Prerequisite: None. Credit: 2.
 
CRP 259 Decision Sciences in Clinical Research
Modeling the potential impact of a health intervention on disease outcomes can be extremely useful in gaining an understanding of the underlying biology or epidemiology of a disease, in designing research studies, and in assessing whether an intervention is economically feasible. This course focuses on basic modeling techniques, with an emphasis on decision analysis and cost-effectiveness analysis, and the application of these techniques to the student's own research. Topics covered include basic decision theory, basic principles of economic analysis in health care, decision trees, Markov models, infectious disease models, and economic analysis of clinical trials, how to review a decision/cost-effectiveness analysis, and the application of models for research and policy analysis. Prerequisite: CRP 242.  Credit: 2.
 
CRP 262 Systematic Reviews and Meta Analysis
This course provides a practical foundation for systematic reviews involving quantitative synthesis (quantitative meta analysis). Through directed exercises, students learn when and how to perform quantitative synthesis using freely available software. Topics include: computing effect sizes, computing a combined effect, fixed effect vs. random effects analyses, heterogeneity in effect sizes, and methods to detect publication bias. Note: This course is offered in even-numbered years only.  Prerequisites: CRP 241 and CRP 242. Credit: 2. 
 
CRP 263 Longitudinal Data Analysis
Longitudinal methods are required in the analysis of two types of study designs, those that involve questions about systematic change over time and those that involve questions about whether and when events occur.  The first type is characterized by repeated observations of the same variables over time, allowing the analysis of temporal changes.  In the second type, commonly referred to as time-to-event designs, the outcome of interest is the time to an event such as death or hospitalization.  The course covers the design, analysis and interpretation of these types of studies.  Various models, methodological issues and methods of analysis are discussed and demonstrated using R, SAS and Enterprise Guide.  Lectures are supplemented with readings from texts and journal articles.  Prerequisite: CRP 245. Credit 2.
  
CRP 264 Introduction to Immunology in Clinical Research
Using a “flipped classroom” design, this course presents two major aspects of Immunology.  First, it provides an introduction to the fundamental concepts of immunology and its role in human disease in a series of videos that are downloaded and watched prior to attending the class.  Second, it provides a comprehensive review of cutting edge immune diagnostic and therapeutic strategies as they are applied to human disease in a series of student led in-class topic reviews and discussions.  Emphasis is placed on the application of immunology to oncology, infection, autoimmunity, and transplantation. The curriculum is customized to match the interests of the students enrolled. Prerequisite: None. Credit: 2

CRP 265 Molecular Biology Techniques
This course is an introduction to basic laboratory techniques in molecular biology.  Through lectures and hands on laboratory experiments students are introduced to methods required to perform basic molecular biology techniques.  Techniques covered in the workshop include polymerase chain reaction (PCR), Western blotting, nucleic acid isolation, cloning, protein expression and siRNA amongst others.  No laboratory experience is required.  Prerequisite: Permission of the instructor. 2 credits.
 
CRP 266 Concepts in Comparative Effectiveness Research
This course provides students a foundation in comparative effectiveness research (CER) as applied to existing data sets.  Through course readings, in-class discussions, and development of an abstract for submission to a scientific meeting, students develop research skills and competencies related to understanding, conducting and interpreting CER.  Topics include: quasi-experimental study designs, sensitivity analysis and statistical adjustment in quasi-experiments, controlling for bias in observational data, and critical review of clinical literature.  Prerequisite CRP 242. Credit: 2.
 
CRP 267 Special Topics
Not currently offered
 
CRP 270 Research
An individualized research project under the direction and supervision of the student's mentor and examining committee forms the basis for this culmination of the program of study leading to the degree. Credit: 12. (Degree Requirement)
 
CRP 271 Patient-Reported Outcomes in Clinical Research
Patient-reported outcomes (e.g., fatigue, pain, physical functioning, social functioning, etc.) can provide great value to research but present significant challenges.  This course provides students with the knowledge necessary to incorporate patient-reported outcomes into observational studies and clinical trials.  Topics include the different types and suitability of measures, the development of new measures, and techniques for analyzing and interpreting patient-reported outcomes. Prerequisite: CRP 242. Credit: 2. 

CRP 273 Implementation and Dissemination of Health Care Research
Implementation research (1) seeks to understand the processes and factors that are associated with successful integration of evidence-based interventions within a particular setting (e.g., a worksite or school), (2) assesses whether the core components of the original intervention were faithfully transported to the real-world setting (ie, the degree of fidelity of the disseminated and implemented intervention with the original study), and (3) is also concerned with the adaptation of the implemented intervention to the local context.  This course provides an overview of methods for undertaking research and program evaluation within health services organizations and systems. A particular focus will be on healthcare products and how to evaluate their impact on various stakeholders whether individual patients, family, health care providers, healthcare systems, or policy makers.  In addition to methods, the course also provides "the state of the art" in research and evaluation through the review of major completed studies. Case studies of recent programs and technologies will be used. This course is recommended for students who will be carrying out policy research, social science research, or program impact evaluation within health delivery systems as well as developing and implementing programs to improve healthcare outcomes.  Prerequisite: None.  Credit: 2.