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Curriculum

Course Descriptions

Required Courses

 

>CTM 5107 Responsible Conduct of Research

1 semester hour

This course provides instruction on the regulatory requirements of clinical research (IRB, GCP, HIPAA, and investigational findings), ensuring patient safety, interactions with government and industry contract negotiations, and successful strategies and tactics.

 

*BSCI 5197 may be substituted with consent of program director.

 

>CTM 5105 Ethics in Clinical Research

1 semester hour

This course is a systematic examination of ethical concepts and standards of responsible conduct in clinical and translational research. Its aim is to provide those training in and/or conducting clinical research a framework in which to recognize, examine, and resolve advanced ethical questions; prevent conflicts in professional work; and prepare for independent research and the mentoring of others.

 

Prerequisite: CTM 5107. *BSCI 5198 may be substituted with consent of program director.

 

CTM 5301 Introduction to Principles and Methods of Clinical Translational Research

3 semester hours

This class presents basic and intermediate level principles in research design; formulation of the research question; identifying primary and secondary structures; use of control groups and pre-specified hypotheses; surrogate measurements; analysis of incomplete data; meaning of P values and confidence intervals; identification of bias and flaws in study design.

 

>CTM 5309 Biostatistics I

3 semester hours

Traditional, mathematical approach to statistical analysis of biomedical data. Topics include data description, summary statistics, elements of probability, distributions of random variables including applications of the binomial and normal distributions, estimation and confidence intervals, hypothesis testing, analysis of variance, correlation and regression and contingency tables. Additional topics include statistical power, sample size and study design.

 

>CTM 5302 Biostatistics for Clinical Sciences II

3 semester hours

This course is a continuation of the basic statistical methods courses applied to the medical and health sciences and is strongly encouraged for all program students. Topics include regression models, analysis of variance models (ANOVA), measures of association, logistic regression, survival analysis, categorical data analysis, and special topics (measurement, meta-analysis, Bayesian analyses, and propensity analysis methods). Techniques for selecting appropriate sample sizes and power are discussed. Many of the statistical analyses will be illustrated with computer output. Journal articles may be incorporated in the lecture sequence to illustrate statistical and design principles.

Prerequisite: CTM 5309; CTM 5307 may be substituted with consent of program director.

 

CTM 5106W Grant Writing & Funding Strategies

1 semester hour

This online course will review the different types of federal grant mechanisms as well as grants or contracts from research foundations, advocacy organizations and industry. How to write a persuasive, well-reasoned application will be the focus of the course including the budget, resources, environment, preliminary data and research plan.

 

CTM 5208 Essentials of Management & Leadership for Researchers

2 semester hours

This course is a structured review and discussion of the basics of management and leadership theory and practice. Topics include project management and budgeting, information systems, leadership style, effective interviewing and hiring techniques, conflict resolution, and the basics of organizational culture. Predominant theories and research, as well as shared experiences of the instructor and group will be discussed in order to enhance each participant’s effectiveness as a manager and leader. It will be a combination of assigned readings, didactic lectures, active group discussion, a mid-term project and final examination.

 

CTM 5209 Practical Clinical and Translational Research Protocol Development

2 semester hours

Practical aspects of research protocol conceptualization and development. Enrollees will learn how to translate a research question into a hypothesis, how to identify and describe hypothesis-appropriate study subjects and study measurements, select a specific study design appropriate to the research question and resources available, synthesize the elements into a study plan, and develop a statistical section and analytical plan. Protocols developed by the students will form the primary basis for group discussions.

 

CTM 5120 Socratic Seminar/Clinical & Translational Science Forum

1 semester hour

The Socratic seminar series consists of a rich selection of presentations conducted using an interactive approach to provide continuous opportunities for investigators to exchange ideas, apply knowledge, present and defend their work, critique the work of others, and participate in forums mimicking real-life conditions of peer review. Students participate in seminars dedicated to their comprehensive understanding of clinical and translational research, careers in academic medicine, and other relevant professional development topics. The Clinical & Translational Science Forum is incorporated with weekly presentations of research proposals to a peer group audience by early-career investigators with lively critiques of substance and style by a panel of senior investigators, with the intent of making key points of interest to all investigators. 

This course must be taken in two semesters to meet the two hour program requirement unless a variance is granted by the program director.

 

 

CTM 5097 Directed Research/Research Practicum

1-6 semester hours

The Directed Research course offers academic credit for research and writing efforts guided by the trainee’s scientific mentor(s) and program leadership. Required deliverables include a research project, publishable manuscript, and extramural grant application. May be repeated for credit with consent of program director.

 

Elective Courses

Additional elective courses from other professional programs at UT Southwestern not listed here may be taken for credit with consent of program director.

 

BSCI 5197 Professionalism, Responsible Conduct of Research and Ethics I

1 semester hour

Topics covered through lectures and small group discussions:

  • Goals of education in responsible conduct of research
  • Professionalism
  • Collaboration
  • Teambuilding and professional behaviors
  • Everyday practice of ethical science
  • Mentorship
  • Data management and reproducibility
  • Animal research
  • Genetics and human research

BSCI 5198 Professionalism, Responsible Conduct of Research and Ethics II

1 semester hour

Topics covered through lectures and small group discussions:

  • Codes of ethics and misconduct
  • Building interprofessional teams
  • Conflict of interest;
  • Sexual boundaries and professional behavior
  • Applications of genetic testing
  • Technology transfer and intellectual property
  • Plagiarism, authorship, and citation;
  • Peer review
  • Image and data manipulation

Prerequisite: BSCI 5197

 

CTM 5115 Clinical and Translational Research from Proposal to Implementation

1 semester hour

This course reviews basic elements for a research proposal and implementation. Topics include:

  • Regulatory approvals
  • Continuing regulatory oversight
  • Monitoring patient safety
  • Recruitment
  • Clinical assessments
  • Data treatment
  • Data collection
  • Entry and auditing
  • Provision of experimental tests and tasks
  • Data analyses
  • Publication planning

 

CTM 5307 Epidemiology for the Clinical Investigator

3 semester hours

Topics covered:

  • Concepts of multivariate causality
  • Criteria for establishing causality
  • Risk
  • Rates
  • Incidence, prevalence and attack rates
  • Incidence density
  • Crude, specific and adjusted rates
  • Relative risk
  • Odds ratio
  • Case-fatality rate and attributable risk
  • Sampling error
  • Selection bias, information bias, definition bias, and confounding bias
  • Statistical techniques to control for bias
  • Multiple comparisons correction
  • Study design to avoid bias
  • Survey and sample selection, cross-sectional design
  • Prospective vs. retrospective studies
  • Attributes of cohort studies
  • Design principles of case-control studies
  • Strategies for matching in case-control studies
  • Experiential introduction to statistical computing for different types of clinical epidemiology studies

 

>CTM 5091 Independent Study

1-3 semester hours

This course is designed for independent or group study as directed by a faculty instructor and mentor. May be repeated for credit with consent of program director.

Prerequisite: consent of program director.

 

>CTM 5096 Special Topics

1-3 semester hours

Special topics review facilitated by graduate research mentor. May be repeated for credit with consent of program director.

Prerequisite: consent of program director.

 

HI 5301 The U.S. Health Care System

3 semester hours

This course provides an important introduction and overview to the American health care system, including familiarization with most actors & organizations comprising our broader health care systems. The course begins with a comparison to other nations’ health care systems and utilizes an internal critique to understand and address issues within the American health system including, but not limited to, public health issues, quality and cost of care, ongoing innovation in medicine and medical education, payment mechanisms, consumer behavior, the legal and regulatory framework, and emergency preparedness. It then articulates the demographic challenges ahead as well as their impact on both household and federal finances. It then provides students with an overview of the various methods and parties used to pay for health care as well as the massive, and at times unnecessary, complexity that imposes unparalleled burdens on physicians, other providers, and on health care delivery organizations. The course will also explore the impact of new technologies across the entire continuum of care, focusing on transitions and care in the home. It concludes with some coverage of both the opportunities and threats posed by rapid technology advancement.

Prerequisite: consent of program director.

 

HI 5302 Health Information Technology

3 semester hours

Students will learn about the current state of health information technology in a variety of clinical settings through a review of systems and tools in practice, the interactions and relationships of various information systems, and the overall architecture of health information systems, data networks, and data flow. Learners will understand the types and structure of health data, as well as principles of data exchange, interoperability, and data integration. HIS accreditation and quality assessment will be taught. An important aspect of the course will be institutional and local data governance. Key concepts of data security and privacy will be taught. This course will further address the use of information technology in health and its impact on care delivery and the healthcare marketplace. Specific topics include the history of Health Informatics, electronic health records, consumer portals, health information exchange, effect of health information tools on quality and safety, clinical decision support, provider order entry, knowledge management, clinical documentation, dash boards, the role of registries (such as immunization registries) and the development and successful execution of new care delivery models using health information technology (e.g., IT-enabled communication, collaborative workspaces, population health tools). After the course, students will be able to describe health information technology and its application, data generated, and functionalities, and discuss how to protect health data.

Prerequisite: consent of program director.

 

HI 5303 Evidence Based Medicine and Clinical Decision Support

3 semester hours

The development and strength of evidence and its application in health care delivery will be the prelude to the design, implementation, operation, and evaluation of clinical decision support (CDS) in the context of electronic health records and other clinical information systems. Topics to be addressed include making clinical decisions, five rights of clinical decision support (information, person, intervention formats, channel, and point/time in workflow), methods of clinical decision support, proper CDS design, implementation and operation of CDS, assessment of CDS, knowledge management in healthcare, legal aspects of CDS including unexpected consequences, and business decision support. Students will be expected to analyze and predict the impact of novel CDS on workflow and provider satisfaction and patient experience, and will be required to develop examples of decision support and complete a CDS project as part of the course. After completion, students will understand and measure strength of evidence, appreciate the principles of evidence based guideline generation, describe tools to make guidelines implementable, and will have evaluated and designed their own CDS solution to a healthcare problem they identified.

Prerequisite: consent of program director.

 

HI 5304 Evidence Data Analytics

3 semester hours

In this course, students will be exposed to scientific methods and processes to extract knowledge and insights from structured and unstructured data. This course will leverage advanced statistics, data analysis, machine learning and related data methodologies to analyze, understand, model, and gain novel knowledge from data. Students will be introduced to clinical epidemiology, predictive analytics, comparative effectiveness, health services research, clinical predication rules, and patient centered outcomes research. Students will learn to apply healthcare analytics including how to apply data in quality and performance improvement and innovation projects. Introduction to research informatics tools such as REDCap, i2b2, and TriNetX will be taught. OMAP will be introduced. Students will learn database design and modeling using a hands on experience. Conceptual model: the logical structure of the entire database. The course will address conceptual schemas, database logical design, entity relationship diagram (ERD), external and internal models, normalization, and data independence (logical and physical). This course will have a heavily applied aspect with students being exposed to tools such as Python, JavaScript, HTML5/CSS, API Interactions, SQL, Tableau, R, and Git/GitHub. Students will be able to describe and utilize basic tools fused data analysis, epidemiology, and statistics.

Prerequisite: consent of program director.