87 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.
Undergraduate and graduate degrees will be conferred sequentially, with the BSHS awarded upon completion of 120 credits (of which 60 credits must be taken at GW; nine of those credits will be graduate level courses that will be taken during the BSHS portion at the undergraduate tuition rate). The MSHS is awarded following completion of an additional 27 credits (9 courses) of graduate coursework. 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 (17 courses; 51 credits)
- CRA 3101 Basics of Clinical Research (3)
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.
- CRA 3102 Processes of Clinical Research (3)
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.
- CRA 3103 Good Clinical Practices (3)
The student analyzes the rationale and goals of Good Clinical Practice (GCP), and applies key principles within the context of case studies.
- CRA 4104 The Business of Clinical Research (3)
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.
- CRA 4107 Introduction to Monitoring Clinical Trials (3)
The role of monitoring in clinical research administration to ensure valid, reliable, and accurate clinical data and adherence to good clinical practices by sponsors and study sites.
- CRA 4125 Capstone in Clinical Research Administration (3)
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.
- COHM 4110 Strategic Communication for Health Professionals (3)
Overview of health communication research, theory, and practice, examining the powerful communication influences on delivering care and health promotion.
- HSCI 2050 Health Equity (3)
The cross-cutting nature of the social determinants of health and clinical and biomedical implications in practice and research settings.
- HSCI 2102 Pathophysiology (3)
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.
- HSCI 2105 Current Issues in Bioethics (3)
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.
- HSCI 2112W Writing in the Health Sciences (3)
Introduction to the health sciences literature Emphasis is on construction, evaluation and organization of written communication of health sciences information.
- HSCI 2117 Introduction to Statistics for Health Science (3)
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.
- HSCI 3114 Management of Health Science Services (3)
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.
- HSCI 4106 Intro to Epidemiology for Health Sciences (3)
An introduction to epidemiological methods and their applications in the prevention and control of illness, community and clinical interventions, and health services.
- HSCI 4112W Research and Writing in Health Sciences (3)
Includes a significant engagement in writing as a form of critical inquiry and scholarly expression to satisfy the WID requirement.
- INFR 4101 Introduction to Medical Informatics (3)
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.
- RAFF 3101 Introduction to Regulatory Affairs (3)
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:
- CTS 6261 Foundations in Clinical and Translational Research (3)
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.
- HSCI 6263 Biostatistics for Clinical and Translational Research (3)
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.
- HSCI 6264 Epidemiology Translational Research (3)
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.
MSHS Core (9 courses; 27 credits)
- CTS 6201 Critical Analysis of Clinical Research (3)
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”.
- CTS 6205 Clinical Investigation (3)
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.)
- CTS 6246 Clinical and Translational Research Capstone Project (3)
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.)
- CTS 6265 Grantsmanship in Translational Health Science (3)
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.
- CTS 6273 Bioinformatics for Genomics (3)
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.
- CTS 6275 Transdisciplinary Research Proposal (3)
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.
- CTS 6285 Collaborative and Team Science (3)
Approaching health, technology, social, and environmental problems with cross-disciplinary engagement and collaboration. Foundational and practical principles and their impact on collaborative and team science engagements. Credit cannot be earned for this course and HSCI 6285.
MSHS Elective - Select 2
- RCR 6201 Introduction to Global Regulatory Affairs and Clinical Research
Foundation of regulatory affairs and clinical research in therapeutic development in U.S., EU and Japan. Roles in developing products, navigating the regulatory review and approval process, and maintaining products on the market.
- RAFF 6204 Clinical Research for Regulatory Affairs (3)
The planning and conduct of clinical trials. Topics include protocol development, study design, post-marketing surveillance, and evaluation and assessment of regulatory submissions. Strategies for achieving clinical development goals. Prerequisite: RCR 6201
- HSCI 6223 Topics in Health Care Leadership (3)
Students examine leadership/leadership change theories in the healthcare industry setting, as well as management and communications strategies, and values in a systems framework. Theories and styles of leadership, including organizational management and values, strategic planning, communication strategies, managing change, and negotiating conflict in the context of the health care delivery system.
- HSCI 6240 Issues and Trends in Health Systems (3)
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.
- HSCI 6241 The Health Care Enterprise (3)
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.