MS in Clinical Research

The Master of Science in Clinical Research Program (MSCR) provides training in clinical research for health care professionals whose careers in academic medicine would require successful and consistent extramural funding as principal investigators on grants, implement clinical research projects and produce clinical science publications. The program prepares health care professionals for development and opportunities to further their skills in the clinical research environment and workforce. The MSCR Program is a component of the educational core of the South Carolina Clinical and Translational Research Institute (SCTR), and is compliant with core competencies recommended by the National Center for the Advancement of Translational Sciences. The degree is granted through the College of Graduates Studies.

At the end of the program, students should be able to:

1. Conduct a comprehensive and systematic review of the literature
2. Formulate a well-defined clinical or translational research question
3. Select an appropriate study design to address a clinical or translational research question
4. Compute, describe, and evaluate descriptive and inferential statistics appropriate to the chosen study design
5. Apply ethical codes and professional standards for the conduct of clinical and translational research

Course Descriptions
Curriculum
Part-time Curriculum
Full-time Curriculum
Certificate Program Curriculum (Part-time)

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 724-01 Introduction 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 725-01 Grants Development for Clinical Research - The objective of the course is to prepare the student to develop a draft grant application, the sections of a grant, IRB regulations and procedures, what reviewers look for and how to think like a reviewer, ethics, and developing a research budget. Students will be given examples of successful grants and grants that have not been funded to discuss and critique.

MCR 731-01 Critical Review of the Literature- 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.

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.

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 738-01 Clinical Research Introductions - This course provides students with the basic structure of clinical research, mentorship, resources for professional research available throughout the campus. Emphasis will be placed on a variety of clinical research conducted on MUSC's campus.

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 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.

MCR 752-01 Team Science in Clinical Research - An emphasis will be placed on the competencies and processes associated with the concepts of team science in translational research necessary to review the scientific literature. Solving complex societal problems (e.g., environment, poverty, cancer, healthcare) requires the integration of specialized knowledge bases.

MCR 789-02 Innovation in Clinical Researcher Placement - Innovation has become an important component of academic and scholarly activities and, as such, achievements in innovation should be recognized as essential part of the academic clinical research role, as well as a consideration for promotion and tenure for the academician in clinical research. Metrics and recognition in research, education, clinical services all covered in the course.

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 789-04 ST: Community Engagement Research - This course provides a foundation for incorporating the principles and methods of CEnR, dissemination, and implementation in the development of community-academic research partnerships and implementing best practices. Topics include different levels of engaging communities in research, as well as the research processes, ethics and responsible conduct in CEnR, and various examples and strategies to involve communities in the research processes including dissemination and implementation of research findings.

MCR 789-07 ST: Industry/Regulatory -The course focuses on the conduct of clinical research, whether an investigator-initiated study or participation as a site in an industry sponsored clinical trial. It will present in detail all aspects of clinical research including assessment of opportunities and feasibility, building a budget, negotiating contracts, managing regulatory requirements, and understanding intellectual property.

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 as a co-requisite.

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 patient populations.

MCR 789-20: Introduction to Grant Writing for Clinical and Translational Research - The course will function as an interactive description of the research grand mechanisms, application process, review process and implementation. The different types of grants will be presented and the details of the application and peer review. The source of funding will be described. Students will learn an overview of the types of grants, potential funding sources, how to get started and resources available at MUSC.

MCR 789-32 ST: Leadership - This 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 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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Curriculum

Students complete the program in two years on a part time basis, beginning each fall. Individuals admitted to this program complete a 38-academic credit hour master's program which is composed of classroom lectures and seminars.

Part-Time Curriculum

Fall Semester

MCR 700-01 Clinical Biostatistics: 3 semester hour

MCR 736-01 Clinical Epidemiology: 3 semester hours

MCR 750-01 Ethical Issues in Clinical Research: 1 semester hour

MCR 789-13 Contemporary Topic Seminar: 1 semester hour

Spring Semester

MCR 724-01 Introduction to Clinical Trials: 3 semester hours

MCR 724-01 Informatics and Data Management: 2 semester hours

MCR 752-01 Team Science in Clinical Research: 1 semester hour

MCR 789-03 Regression Analysis for Clinical Research: 2 semester hours

Summer Semester

MCR 731-01 Critical Review: 2 semester hours

MCR 789-04 Community Engagement Research: 1 semester hour

MCR 789-07 Industry/Regulatory: 2 semester hours

MCR 789-32 Leadership: 2 semester hour

MCR 970- Mentored Research: 1 semester hour

Fall Semester

MCR 725-01 Grants Development for Clinical Research: 2 semester hours

MCR 732-01 Comparative Effectiveness Research: 3 semester hours

MCR 789-08 Core Clinical Research Training: 1 semester hour

MCR 970- Mentored Research: 2 semester hours

Spring Semester

MCR 970  Mentored Research: 5 semester hours

MCR 789-02 Innovation in Clinical Researcher Placement 1 semester hour

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Full-Time Curriculum

The program is designed for students who are currently pursuing doctoral degrees in the six colleges (Medicine, Dental Medicine, Nursing, Pharmacy, Graduate Studies and Health Professions) as well as international applicants. Students complete the program in one year on a full-time basis.

Fall Semester

MCR 738-01 Clinical Research Introductions: 1 semester hour

MCR 700-01 Clinical Biostatistics: 3 semester hours

MCR 731-01 Critical Review: 2 semester hours

MCR 736-01 Clinical Epidemiology: 3 semester hours

MCR 750-01 Ethical Issues in Clinical Research: 1semester hour

MCR 789-13 ST: Contemporary Topic Seminar: 1 semester hour

MCR 970- Mentored Research: 2 semester hours

Spring Semester

MCR 724-01 Introduction to Clinical Trials: 3 semester hours

MCR 732-01 Comparative Effectiveness Research: 3 semester hours

MCR 746-01 Informatics and Data Management for Clinical Research: 2 semester hours

MCR 752-01 Team Science in Clinical Research: 1 semester hour

MCR 789-03 ST: Regression Analysis for Clinical Research: 2 semester hours

MCR 789-20 ST: Introduction to Grant Writing for Clinical and Translational Research: 1 semester hour

MCR 970 Mentored Research: 3 semester hours

Summer Semester 

MCR 789-04 ST: Community Engagement Research: 1 semester hour

MCR 789-07 ST: Industry/Regulatory: 2 semester hours

MCR 789-08 ST: Core Clinical Research Training: 1 semester hour

MCR 789-32 ST: Leadership: 2 semester hours

MCR 970 Mentored Research: 4 semester hours

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Certificate in Clinical Research (CCR) Part-Time (19 Hours)

The Certificate in Clinical Research Clinical is ideal for specialists, residents and fellows who desire to accrue the core competencies to participate in clinical research without pursuing a graduate degree. Candidates are required to complete 19 credit hours for completion.

Fall Semester-(Courses are offered in this semester and taken accordingly) 

MCR 700-01 Clinical Biostatistics: 3 semester hours

MCR 736-01 Clinical Epidemiology: 3 semester hours

MCR 750-01 Ethical Issues in Clinical Research: 1 semester hour

MCR 731-01 Critical Review: 2 semester hours

MCR 732-01 Comparative Effectiveness Research: 3 semester hours

Spring Semester-(These courses are offered in this semester and taken accordingly)

MCR 724-01 Introduction to Clinical Trials: 3 semester hours

MCR 752-01 Team Science in Clinical Research: 1 semester hour

MCR 789-20 ST: Introduction to Grant Writing: 1 semester hour

MCR 732-01 Comparative Effectiveness Research: 3 semester hours

Summer Semester – (Part-time hours)

MCR 731-01 Critical Review: 2 semester hours

MCR 789-07 ST: Industry/Regulatory: 2 semester hours

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Contact:
Maritza Dawkins- Holnes
Program Coordinator
dawkin@musc.edu
843-876-2216

Application Requirements