Certificate in Clinical Science

Accreditation

The program is accredited under the authority of the Southern Association of Colleges and Schools Commissions on Colleges (SACSCOC).

Requirements for Admission

Requirements for Admission

Applicants must have minimally earned a bachelor’s degree or its equivalent from an accredited institution in the United States or proof of equivalent training at a university in another country.

A finalized and submitted online application will include:

  • Transcripts from all post-high school institutions (for determination of grade point average)
  • Test of English as a Foreign Language (TOEFL) exam scores (for international applicants only)
  • Three letters of recommendation (the names and email addresses of the references will be required at the time of application)
  • A curriculum vitae or resume
  • A personal statement describing background experiences, pertinent training, and personal motivation for a career in applied clinical research

When evaluating applicants, the Admission Committee will holistically consider the following:

  • Letters of recommendation
  • Grade point average
  • Undergraduate and graduate degree curriculum breadth and rigor
  • Personal statement and motivation for a career in scientific research
  • Personal integrity
  • English language competency

Applicants deemed to be the most qualified will be offered a seat in the program. Offers to enroll in the program will be made based on a holistic evaluation of all required submission materials.

 

Essential Functions

Essential Functions

In addition to essential functions for all Health Professions students (see Entrance Requirements in the Student Information chapter), each student in the Master’s in Clinical Science program must be able to:

  1. Observe and perform laboratory and/or clinical tests in which human subjects, animals, chemicals, and/or biological materials (e.g. body fluids, culture materials, tissue sections) are tested for their physical attributes including, but not limited to, movement, force, texture, color, sound, odor, viscosity, and immunological, microbiological, and histochemical components.
  2. Move freely and safely about a laboratory and clinic.
  3. Recognize potentially hazardous material, equipment, and situations and proceed safely in order to minimize risk of injury to human subjects, self, and other individuals.
  4. Control equipment and adjust instruments to perform laboratory procedures.
  5. Travel to numerous laboratory/clinical sites.
  6. Effectively, confidently, and sensitively converse with human research subjects.
  7. Communicate effectively and efficiently with faculty members, fellow students, staff, and other members of the research and health care community to convey information essential for studying and conducting research.
  8. Manage the use of time to be able to systematize actions in order to complete professional and technical tasks with realistic constraints.
  9. Support and promote activities of fellow students and health care and research professionals. Promotion of peers helps to facilitate a team approach to learning, task completion, problem solving, and patient care.
  10. Be honest, compassionate, and responsible.
  11. Demonstrate professional demeanor and behavior; perform in an ethical manner in all dealings with peers, faculty, staff, and patients.

Curriculum

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 Science

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 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. 

 

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. 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: CTM 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 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 5106 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 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.

Certificate Requirements

The program curriculum is designed for full-time (nine hours per fall/spring semester; six hours per summer semester) or part-time enrollment. A minimum of 15 hours of required and elective courses must be completed to earn the Basic Certificate in Clinical Science.

In total, degree requirements include completion of a combination of required courses, electives (if applicable), and research activities (i.e. completion of a research project).

Coursework

All coursework (required and elective) has been designed to primarily provide training in experimental design, methodology, biostatistical analyses and research ethics as well as the conduction of scientific experimentation.

Research Activities

In addition to coursework, students will be involved in research projects that will lead to completion of required program deliverables (i.e. research project, publishable manuscript and extramural grant application) requisite to earn the Master’s in Clinical Science degree. Students will select a research mentor to facilitate and supervise research activities.

Prescribed Sequence of Courses

The following is the recommended sequence of required courses for the Master’s in Clinical Science program:

Requirements

Total Credit Hours:48

FALL COURSES

CTM 5097DIRECTED RESEARCH/RESEARCH PRACTICUM

1-6

CTM 5107RESPONSIBLE CONDUCT OF RESEARCH

1

CTM 5301INTRODUCTION TO PRINCIPLES AND METHODS OF CLINICAL TRANSLATIONAL RESEARCH

3

CTM 5309BIOSTATISTICS I

3

Fall
Total Credit Hours:9
Spring
BSCI 5198ETHICS MODULE II

1

Or

CTM 5106WGRANT WRITING & FUNDING STRATEGIES

1

ACR 5302BIOSTATISTICS II

3

ACR 5101GRANT WRITING I

1

ACR 5094RESEARCH PRACTICUM

1 to 3

ACR 5112PROFESSIONAL DEVELOPMENT II

1

Total Credit Hours:9

SPRING COURSES

CTM 5097DIRECTED RESEARCH/RESEARCH PRACTICUM

1-6

CTM 5105ETHICS IN CLINICAL SCIENCE

1

Fall
ACR 5107DOCTORAL SEMINAR I

1

ACR 5099DISSERTATION

3 to 9

ACR 5201TEACH & LEARN HLTH CARE EDU

2

ACR 5114SCIENTIFIC COMMUNICATION

1

TBD
Elective Coursework

2

Total Credit Hours:9

COURSES OFFERED IN MULTIPLE SEMESTERS

CTM 5120SOCRATIC SEMINAR/CLINICAL & TRANSLATIONAL SCIENCE FORUM

1

CTM 5097DIRECTED RESEARCH/RESEARCH PRACTICUM

1-6

Special Requirements

Portions of the curriculum are sequenced. Therefore, some courses included in each semester or term are considered prerequisites to courses in the following semester. A student must complete each course with a minimum grade of C or Pass, depending on the course grading system, maintaining a cumulative GPA of at least 3.0 and have no academic deficiencies. The student is advised to consult the policy statement of the department upon admission to the program.

Graduation Requirements

A candidate for the Master’s in Clinical Science degree in the UT Southwestern School of Health Professions must meet all of the following requirements:

  1. The student must demonstrate a high order of scholarly achievement including appropriate research competencies. The student’s mentor and program leadership determine whether adequate mastery in research has been acquired.
  2. The student must satisfactorily complete a minimum of 36 semester hours in the Master’s in Clinical Science program at UT Southwestern School of Health Professions.
  3. The student must discharge all financial obligations to the Medical Center. In the event of nonpayment, one or more actions may be taken by the Dean: a) readmission may be denied; b) the student’s grades and official transcript may be withheld; and c) the degree to which the student would otherwise be entitled to may be withheld.
  4. The student must maintain at least a 3.0 cumulative grade point average, have no academic deficiencies, and have no incompletes.
  5. The student must complete the academic requirements listed in his or her degree plan by the times stated in the student’s official letter of acceptance. The student is responsible for submitting official documentation of successful completion to the Office of Enrollment Services.
  6. The student must complete all requirements for graduation within three years of the original date of matriculation unless an extension period is granted by the Program Director and approved by the Dean of the School of Health Professions.

Faculty

Program Directors

Scott A. Smith, Ph.D.; University of North Texas Health Science Center, 1999

Chair, Department of Applied Clinical Research

Heidi Jacobe, M.D., Baylor College of Medicine, 1996; M.S.C.S., UT Southwestern Medical Center, 2008

 

Professors

Keith Argenbright, M.D., Tulane University, 1984; M.M.M., Carnegie Mellon University, 2009

Robert Haley, M.D., UT Southwestern Medical Center, 1986

Elizabeth Heitman, Ph.D., Rice University, 1988

Linda Hynan, Ph.D., University of Illinois at Urbana-Champaign, 1993

Heidi Jacobe, M.D., Baylor College of Medicine, 1996; M.S.C.S., UT Southwestern Medical Center, 2008

Joan S. Reisch, Ph.D., Southern Methodist University, 1974

Scott A. Smith, Ph.D.; University of North Texas Health Science Center, 1999

Robert D. Toto, M.D., University of Illinois at Chicago, 1977

Helen Yin, Ph.D., Harvard University, 1976

 

Associate Professors

Karen Brewer-Mixon, Ph.D., CRC; UT Southwestern, 1996

 

Assistant Professors

Stuart Ravnik, Ph.D.; University of Washington, 1991; Associate Dean, UT Southwestern Graduate School of Biomedical Sciences

Jijia Wang, Ph.D.; Southern Methodist University, 2019