This is a 32 credit, 1-year, full-time curriculum designed for the recently graduated MD to pursue before entering a traditional training track. The program will educate the student in the process and methods of clinical research. The program will be taught by distance learning; the student would complete certain courses online, and complete the remainder of courses by traveling to Tulane to attend classes in 4 weekend-long sessions scheduled throughout the year. Classes will begin July 2013. Applications must be completed by April 30, 2013.
Course # Course Title Credit Hours Format
BIOS 6030 Introductory Biostatistics 3.0 DL
EPID 6030 Epidemiological Methods I 3.0 DL
MSCR 7070 Molecular Medicine 4.0 DL
BIOS 6230 Computer Packages 1.0 DL
BIOS 6040 Intermediate Biostatistics 3.0 DL
MSCR 7080 Cultural Competence 3.0 DL
MSCR 6430 Topics in Clinical Research 3.0 DL
HSMG 6030 Principles of Health Sys Admin & Management 3.0 DL
MSCR 6420 Responsible Conduct of Research/Ethics 1.0 DL
MSCR 7150 Seminar/Journal Club 2.0 WK 1,2,3,4
MSCR 6439 Protocol Process 3.0 WK 1,2 & 3
MSCR 7400 Audit Experience 3.0 WK 3 & 4
TOTAL CREDIT HOURS 32.0
DL = Distance Learning
WK = Weekend Class
Students would travel to New Orleans for 4 weekends of intensive coursework. The weekends would be spread across the 1 year of curriculum time
SAMPLE COURSE SCHEDULE
Credit Hours Format
Summer Yr 1 MSCR 6430, Topics in Clinical Research 3.0 DL
MSCR 6420, Resp Conduct of Research 1.0 DL
BIOS 6030, Introductory Biostatistics 3.0 DL
Fall Yr 1 MSCR 7070 Molecular Medicine 4.0 DL
EPID 6030, Epid Methods I 3.0 DL
BIOS 6230/40, Computer Packages 1.0 DL
Weekend 1 MSCR 6439, Protocol Process 1.0 WK
Sept 2012 MSCR 7150 Journal Club 0.50 WK
Weekend 2 MSCR 6439, Protocol Process 1.0 WK
Nov 2012 MSCR 7150 Journal Club 0.50 WK
Spring Yr 1 BIOS 6040, Intermediate Biostatistics 3.0 DL
HSMG 6030, Hlth Sys Admin & Mngt 3.0 DL
MSCR7080, Cultural Competence 3.0 DL
Weekend 3 MSCR 6439, Protocol Process 1.0 WK
Mar 2013 MSCR 7150 Journal Club 0.50 WK
MSCR 7400 Audit Experience 1.5 WK
May 2013 MSCR 7150 Journal Club 0.50 WK
MSCR 7400 Audit Experience 1.5 WK
TOTAL CREDIT HOURS 32.0
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.
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.
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.
HSMG 6030 Principles of Health Systems Administration and Management 3.0
Non-MHA students only.
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 6420 Responsible Conduct of Research/Ethics 1.0
(10 week course, 1 hr/wk)
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.
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.
MSCR 6439 Protocol Process 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.
MSCR 7070 Molecular Medicine 4.0
Clinical and translational research in the medical school setting will have a heavy focus on discovery, development, and application of "targeted therapy". The Molecular Medicine Course (3 credits) will review the molecular pathophysiology of diseases that have broad implications on health. For instance, obesity and metabolic syndromes will be addressed as molecular risk factors for cardiovascular disease, cancer, diabetes, and neurodegenerative diseases; molecular pathways of inflammation will be addressed as risk factors for cancer, atherosclerosis, arthritis, and gastrointestinal disorders. Potential molecular targets for drug development and the experimental sequence from discovery to clinical trial will be emphasized.
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 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 7400 Audit Exercise 3.0
During 2 weekend sessions, Scholars will audit a clinical research study simulating an audit that may be performed by an FDA Team or a Pharmaceutical Sponsor.
Prior to the first weekend session, the Scholars will study the protocol and prepare the audit forms. During the weekends the Scholar will review research procedures and verify that submitted data is complete and verified by primary data. Each scholar will participate in an audit briefing at the end of the second weekend session.
The Executive MS in Clinical Research Methods is a flat rate tuition of $30,000, plus semester fees, paid in 3 equal installments each semester. Travel expenses are the responsibility of the student.
1430 Tulane Avenue, SL-68, New Orleans, LA 70012 504-988-6061 firstname.lastname@example.org