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Master of Science Clinical Research Methods

Program Overview & Curriculum

This is a 32-credit, one-year curriculum is designed for the MD who seeks familiarity with the fundamentals and techniques of clinical research. The curriculum is intended to serve the recent medical school graduate who will earn the MS degree during one year of study following medical school and prior to standard graduate medical education. The program is offered in traditional lecture, seminar and tutorial format on the Tulane University School of Medicine campus; therefore the student would be a resident of the New Orleans area and pursue classes full time. Classes will begin July 7, 2014. Applications must be submitted by May 2, 2014.

Sample Course Schedule

SUMMER SEMESTER

MSCR 6420

Responsible Conduct of Research

1.0

MSCR 6430

Topics in Clinical Research

3.0

BIOS 6030

Introductory Biostatistics

3.0

TOTAL CREDITS

 

7.0

 

FALL SEMESTER

EPID 6030

Principles of Epidemiology

3.0

MSCR 6450

Therapeutics Seminar

4.0

BIOS 6230 or 6240

Computer Packages

1.0

MSCR 7150

Journal Club/Seminar

1.0

TOTAL CREDITS:

 

9.0

 


SPRING SEMESTER

MSCR 6439

Protocol Design and Writing

3.0

BIOS 6040

Intermediate Biostatistics

3.0

GHSD 6030

Health Sys Admin & Mngt

3.0

MSCR 7080

Cultural Competence

3.0

MSCR 7150

Journal Club/Seminar

1.0

MSCR 7300

Clerkship

3.0

TOTAL CREDITS:

 

16.0

 

TOTAL CREDITS:

 

32.0

 

Course Descriptions

MSCR 6420 Responsible Conduct of Research 1.0
This course will cover basic principles of bioethics and their specific application to clinical research. Special attention will be paid to the ethical obligation of the researcher to the participant within the broader framework of patient care and the ethics of caring. Specific challenges of vulnerable populations and research in a global community will also be considered. This course will also cover differences between clinical research and clinical practice, responsibilities regarding data records, data ownership, collaborative and multi-site issues and authorship. Substantive information will be provided about how to conduct clinical research in an ethical manner, especially in the complex and competitive research environment. This course will define research misconduct, falsification and fabrication, with numerous examples to assist in areas that may not be regulatory. Conflict of interest issues present some of the most complex and potentially volatile challenges in the area of clinical research, they will be covered as well.

 

BIOS 6030 Introductory Biostatistics 3.0
Introduction to statistical methodology in the health field. Topics covered include presentation of data (graphs and tables), descriptive statistics, concepts of probability, estimation of parameters, hypothesis testing, simple linear regression, correlation, and the analysis of attribute data. The course is recommended for students needing a firm foundation in statistical methods either for their careers or for preparation for further quantitative courses.

 

MSCR 6430 Topics in Clinical Research 3.0
In this course, students will study IRB relations and regulations, discuss the required elements in a clinical research contract and the responsibilities of the clinical researcher, identify effective use of research personnel, and develop negotiating skills to facilitate support for clinical research. The course will also encompass the principle of randomization and "intention-to-treat" analysis in experimental studies, integration of clinical trials and lab support, specimen collections and laboratory problem based learning. A researcher/clinician centric insight into the logistics of technology transfer and intellectual property (IP) development will be studied. The practical aspects of technology transfer in an academic context will be investigated. Discussed topics will include local academic tech transfer policy, related procedures and available resources. Career pathways and opportunities open to the clinical researcher in the academic and private sector will be explored and discussed.

 

EPID 6030 Epidemiological Methods I 3.0
The purpose of this course is to prepare students to function effectively as mid-level epidemiologists in public health agencies or other settings. The knowledge base and skills that are the focus of this course are fundamental to the scope of work expected of master's degree graduates in epidemiology. The course focuses on epidemiologic approaches to activities that are a routine part of public health practice.

 

MSCR 6450 Therapeutics Seminar 4.0
This course will provide an opportunity for active participation by the students in analyzing current translational literature and understanding the process by which therapeutic progress is made.

 

BIOS 6230 or 6240 Computer Package 1.0
Use of statistical packages (6230: SAS; 6240: SPSS) and an introduction to mainframe computing with transmission of data.

 

MSCR 7150 Seminar/Journal Club 2.0
(1 credit/semester x 2 semesters)

Monthly conference at which students will present and discuss clinical research proposals and published literature.

 

MSCR 6440 Protocol Design and Writing 3.0
Core course discussing the elements of effective research design, including the basic concepts in clinical trials, the main aspects for different types of trials such as proof of principle stage, Phase I, II, III and IV, and understanding good clinical research methodology. Course will introduce and address issues, idea and outline of design methodology that cover planning, conducting, analyzing, and assessing clinical trials. Concepts and principles of study finance, costing and budgeting will be discussed.

BIOS 6040 Intermediate Biostatistics 3.0
This is a second course in applied biostatistics. It covers one-way and two-way analysis of variance, repeated measures designs, simple and multiple regression and correlation analyses, analysis of covariance, and logistic regression.

 

GHSD 6030 Principles of Health Systems Administration and Management 3.0
This course presents selected concepts and methods from management practices that are useful in the public health setting. Topics concerning organizational structure, finance, budgeting, human resources, negotiation and others are presented with examples from public health practice.

 

MSCR 7080 Cultural Competence 3.0
This is an interactive course designed to:

  1. Introduce general concepts of health disparities, social determinants of health, and cultural competence;
  2. Apply concepts to real case scenarios through classroom discussions & in the field assignments

 

MSCR 7300 Clerkship 3.0
Scholars will have a hands-on experience with the operations of a clinical research program. Scholars will work with a Tulane faculty and their clinical research group as a trainee member. During the 8 week tenure, the Scholar will evaluate clinical research opportunities, analyze protocol appropriateness vis a vis patient population, analyze resource and personnel needs, budget, and implementation strategies. Scholars will work alongside clinical research staff to evaluate eligibility, provide informed consent, and gather and manage data. Scholars will also work with regulatory personnel to process protocols for IRB and to monitor the protocol progress and process adverse event reports relative to the research study. Prerequisite will be CITI Certification.

 

1430 Tulane Ave, New Orleans, LA 70112 504-988-5263 medsch@tulane.edu