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College of Graduate Studies

Course Descriptions

MCR 700-01 Clinical Biostatistics -An introduction to basic and intermediate statistical techniques used to analyze and interpret data in health sciences and related fields.  Emphasis is on applications of these methods, with just enough derivation to understand the procedures.  Topics include descriptive statistics, graphical methods and probability with applications to epidemiology, discrete and continuous distributions, inference on means, nonparametric methods, and inference on proportions, contingency tables, correlation, analysis of variance, linear regression, logistic regression, and survival analysis.  Students will not be expected to run computer programs, but will learn how to read printout in order to interpret analytical results.

MCR 789-11 ST: Clinical Biostatistics Lab - This course is not a standalone course in statistics, but is meant to be used in conjunction with a statistics course.  This course will provide means for students to do computing in a statistics course and acquire an appreciation for data analysis.  You will learn about the SAS programming language.   You will know enough of the SAS “basics “to be able to find your way around other SAS reference manuals, or even the internet.  And, you will have an invaluable skill to use in the industry or research fields.

MCR 736-01 Clinical Epidemiology - This course provides an introduction to the discipline of epidemiology and its application to public health research and practice. The course is designed to provide a conceptual foundation for epidemiologic research and application, especially study designs, quantitative concepts and methods, analysis, and interpretation.

MCR 789-13 ST:Contemporary Topics Seminar - The seminar was created to meet the thematic area of the core competencies in cross disciplinary training for student awareness of current issues in medical education and to focus on contemporary research study designs and techniques for application in patients populations.

MCR 724-01 Intro to Clinical Trials - An emphasis will be placed on the concepts, study designs and procedures used in the implementation of clinical trials research studies.  The methodology and process used to access and analyze data as well as the collection of data will be described.

MCR 746-01 Informatics and Data Management for Clinical  Research - This course is intended to introduce clinical researchers to research oriented data management and related basic topics in Informatics.  Students taking this course will learn about basic concepts in: relational database design, modern research data capture tools, clinical data warehousing, security risks and mitigations, privacy issues in electronic data, data standards, data mining and other related topics. Students will get hands-on experience with using modern database tools to solve specific scientific problems by attending the course labs.

MCR 789-03 ST: Regression Analysis for Clinical Research - Regression analysis is at the heart of statistics, and a sound knowledge of regression methods will serve students well as they design and conduct research projects. We begin with simple linear regression and then consider extensions such as multiple predictors, nonlinear effects, categorical predictors, and interactions. Students will learn to evaluate model fit using statistics such as t, F, and R2 in addition to informal analysis based on observable data patterns.  We will rely heavily on graphical representations of the data and make use of plots of regression residuals.  Concepts and techniques of regression analysis will be taught based on carefully developed examples. This course is intended for anyone involved in analyzing data, but who does not specialize in statistics.  We will use computer software (mainly SAS) to examine data output, but students will only be required to read and understand the output.  Students are not responsible for computer programming.

MCR 789-08 ST: Core Clinical Research Training - This course prepares participants to coordinate cost-effective health care research which protects the rights and safety of human subjects, achieves recruitment and retention outcomes and contributes to the science of health care.  Participants completing the training will be prepared to coordinate research studies in compliance with the Good Clinical Practice Guidelines and federal regulations concerning human subject research.  All participants of this course are required to take the CITI MIAMI Good Clinical Practice and ICH Basic Course as a pre-requisite.

MCR 731-01 Critical Review of the Literature- This course is required for the Master of Science in Clinical Research. It is assumed that students in this class have a solid foundation in research design and both parametric and nonparametric statistics. An emphasis will be placed on the competencies and processes necessary to review the scientific literature. In particular, the students will review the published and unpublished literature associated with clinical research results. The focus of the class will be the review of the types of scientific and clinical research manuscripts papers and reports produced from different study approaches.  The course will identify resources for the critical review of the scientific literature.  The considerations and criteria for critical review of the literature will be addressed in the course. Students will prepare written critiques of selected literature and manuscripts.

MCR 789-04  ST:Community Engagement Research - Community engagement is an important element of the successful translation of research from bench to bedside and community. “Community-engaged research” (CEnR) is an approach to conducting research that requires partnership development, cooperation and negotiation, and commitment to addressing local health issues of the community of interest. At the heart of all CEnR is the understanding that community members will be involved in some meaningful way in the research process. This course provides a foundation for incorporating the principles of community engagement in the development of community-academic research partnerships and implementing best practices of CEnR. Topics include community interaction, partnership development, ethics and responsible conduct in community-engaged research, strategies to engage communities across all phases of the research process, and community-based dissemination.

MCR 789-07 ST: Industry/Regulatory - Input from the pharmaceutical industry will guide course content as to the roles, responsibilities, and expectations for a successful collaboration between industry and the principal investigator.  There will be considerable attention on developing budgets, managing research coordinators, reporting events, and participation in FDA monitored trials, Phase I trials, Phase II trials, Phase III trials, Investigational New Drug, and Orphan drug studies.  In addition, this new course will cover the regulatory oversight of clinical trials and the guidance as outlined in Good Clinical Practice as provided for from the International Conference on Harmonisation.

MCR 789-32 ST: Leadership - This online course introduces the major historical and contemporary theories of leadership in the workplace with emphasis on the principles and application of leadership skills. The course will include the study of organization structures, principles, techniques and processes as they relate to practice in and management of health services and research organizations.  Students should gain a better understanding of organizational behavior issues such as motivation, leadership, communication, interpersonal conflict, group dynamics, organizational structures, and meeting procedures.

MCR 725-01 Grants Development for Clinical Research - This course is required for participants in the Clinical Master’s program. The objective of the course is to prepare the student to develop a draft grant application by teaching them about grantsmanship, helping them to develop the sections of a grant, teaching them about IRB regulations and procedures, what reviewers look for and how to think like a reviewer, about ethics, and about developing a research budget. Students will be given examples of successful grants and grants that have not been funded to discuss and critique

MCR 732-01 Comparative Effectiveness Research - This course explores the scope of outcomes studies for evaluating the effectiveness of medical care by emphasizing the development of study designs matched to the research question. The course explores frequently used observation study designs, techniques for evaluating and selecting health outcomes measures, and analytical approaches appropriate to conducting health outcomes research. This course will also cover the approaches used for interpretation and translation of CER data through decision models to compare the cost effectiveness of treatments. Decision analysis models are predictive mathematical models that are used to structure CER and cost data to help inform evidence-based decision choices.

MCR 750-01 Ethical Issues in Clinical Research - An emphasis will be placed on the ethical issues associated with clinical research and practice. The focus of the class will be the review of the competencies involved in the conduct of ethically responsible research. The process of assessing ethical issues in research and study will be described. The ethical considerations in study design; study implementation, data management, data analysis, data Interpretation and results presentation and publication will be described. As future educators, the students will be presented with the honor council process, assessment process for unethical classroom and study behavior, and the process for behavior modification and remediation. The ethical considerations involved with collaborative research will be presented. The course will consider evolving ethical issues in clinical research including the human subjects and conflict of interest. The course will include the use of a class participation system where each student will be able to express their opinion in “real-time”.

MCR 970 Research - This is a varied credit hour research course determined by the student and mentor. A contract between the two includes material covered and deliverables at the end of the semester.



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