147 TOTAL CREDITS REQUIRED
In coursework for the dual BSHS in Clinical Research Administration / MSHS in Clinical and Translational Research, you’ll study clinical research processes and practices, health equity, issues in bioethics, clinical and translational research, the management of clinical trials, and more.
You can complete this degree program in four to five years, and achieve a substitute for some of the professional experience hours required for several certifications through the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA).
BSHS CORE COURSES: The 9 graduate credits students take in lieu of undergraduate electives are: CTS 6261, HSCI 6263, and HSCI 6264.
Overview of health communication research, theory, and practice, examining the powerful communication influences on delivering care and health promotion.
The student explores the different phases of drug and device development and introduces basic concepts such as benefit-risk assessment, the different stakeholders, protocol, informed consent, clinical oversight, institutional review board, Good Clinical Practice (GCP), investigational clinical supplies, data management activities, safety reporting, and monitoring.
The student examines the process steps and regulatory requirements governing the development and registration of investigational new products from different stakeholder perspectives as well as the steps and requirements in the conduct of a clinical trial for an investigational new drug or device while ensuring data integrity and human subjects protection.
The student analyzes the rationale and goals of Good Clinical Practice (GCP), and applies key principles within the context of case studies.
The student compares and contrasts the business priorities of sponsors, sites and third party vendors, such as contract research organizations (CROs); the student also examines the business considerations in preparing clinical trial budgets including outsourcing and potential trial delays.
The student analyzes and evaluates the basic principles and processes involved in the monitoring of clinical trials, as well as the required documentation such as monitoring visit reports; the student also examines the role of key participants with emphasis on the clinical research associate.
In this capstone course, students analyze business, ethical, cultural and practical aspects of clinical trial conduct; explore trends and technologies driving efficiencies in clinical trial performance and demonstrate how ethical and regulatory principles and trial management practices align to ensure quality and compliant clinical research conduct.
The cross-cutting nature of the social determinants of health and clinical and biomedical implications in practice and research settings.
Biomedical and scientific framework for the understanding of human disease mechanisms and biologic processes. Overview of infectious, immunologic, cardiovascular, genetic, respiratory, gastrointestinal, neoplastic, reproductive, renal, hematologic, neurologic, and musculoskeletal diseases.
Basic issues, approaches, and requirements of ethically acceptable decision making with patients, including patient confidentiality, conflicts of interest, allocation of scarce resources, occupational risks in health care, and professional responsibility for overall quality of care.
Introduction to the health sciences literature Emphasis is on construction, evaluation and organization of written communication of health sciences information.
Foundational concepts in descriptive and inferential statistics, including probability, sampling distribution, estimation, correlation, t-Test, simple linear regression, and chi-square. Application of statistical concepts and methods within the health sciences.
Application of management and organizational principles to the delivery of services provided by health sciences disciplines Issues addressed include information systems, leadership, team building, fiscal management, human resources management, quality improvement, and management of conflict and change.
An introduction to epidemiological methods and their applications in the prevention and control of illness, community and clinical interventions, and health services.
Includes a significant engagement in writing as a form of critical inquiry and scholarly expression to satisfy the WID requirement.
Medical informatics applications and innovations in health care and the health care system; implications for health care delivery and patient outcomes, including electronic medical records, health system databases, and medical data analysis.
Introduction to the field of regulatory affairs to regulations, strategies, and laws that apply to safe and effective product development.
THE 9 GRADUATE CREDITS STUDENTS TAKE IN LIEU OF UNDERGRADUATE ELECTIVES ARE:
Overview and analysis of the translational research principles and practice through the application of basic, clinical, community health and health services research concepts. Emphasis is on persuasive communication, conceptually based hypotheses and research methods and the grant application process, including communicating.
Basic concepts and methods of biostatistics applied to translational research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi.
Students explore the basic concepts of epidemiology which includes various epidemiological study designs used to examine disease frequency, cause-effect relationships between risk factors and disease states, and effects of bias as examples. Students apply epidemiologic concepts in the context of translational research.
Students develop the academic skill sets necessary to succeed in this program in the context of exploring scientific, clinical and regulatory concepts required in medicines development. Students demonstrate their critical analysis skills through literature research, analysis of information from various perspectives, and formulating their own opinions in choosing their ‘defendable positions’, rather than stating the “correct answers”.
Analysis and evaluation of study design strategies and current practices for major therapeutic areas of clinical research (e.g., vaccine development, cardiovascular disease, anti-infectives, CNS, etc.)
This class is designed for early independent investigators in Clinical and Translational Research as a capstone This course will allow students to apply the knowledge gained throughout the program through the completion of an independent, mentored research project (i.e., original research manuscript, review article, etc.)
Writing grant proposals to fund clinical research, with an emphasis on translational research proposals. The development and submission of a transdisciplinary research proposal that responds to a Call for Proposals from an external sponsor, such as the National Institutes of Health.
The integration of competencies acquired throughout the program. The development and submission of a transdisciplinary research proposal that responds to a Call for Proposals from an external sponsor, such as the National Institutes of Health.
The integration of competencies acquired throughout the program Foundational and practical principles and their impact on collaborative and team science engagements. Restricted to PhD candidates in translational health sciences; permission of the instructor may be substituted.
Approaching health, technology, social, and environmental problems with cross-disciplinary engagement and collaboration.
MSHS Elective – Select 2
This course sources in the evaluation and assessment of regulatory strategies. Topics include protocol development, study design, post-marketing surveillance, evaluation and, assessment of regulatory submissions. Through the framework of clinical trial design, we evaluate and assess strategies for achieving regulatory strategy in clinical development goals. The course introduces students to the planning and conduct of clinical trials. It provides an overview of clinical trial terminology and discusses issues related to clinical trial design. It discusses the components of a clinical trial including considerations regarding planning and carrying out a study. In the course we evaluate alternative clinical trial design options as conduits for achieving regulatory approval.
Students examine leadership/leadership change theories in the healthcare industry setting, as well as management and communications strategies, and values in a systems framework Students examine topic areas such as populations, sample selection, variables, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi-square analysis. Students examine output from statistical software (SPSS and SAS), practice problems and reviews of scientific literature through assignments such as a research analysis plan.
Students examine the major themes on healthcare policies, trends, and issues in the major health systems and research enterprise Students apply epidemiologic concepts in the context of translational research.
An overview of global business principles related to health care systems: the management of patient-centered care delivery, marketing, finance and fiscal management principles, information technology, and quality improvement.
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