87 TOTAL CREDITS REQUIRED
This multi-level online dual-degree program offers academically qualified individuals a seamless and accelerated pathway for completing both the Bachelor of Science in Health Sciences (BSHS) in Clinical Research Administration and the Master of Science in Health Sciences (MSHS) in Clinical Research Administration
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 that includes including one elective course.
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.
Overview of health communication research, theory, and practice, examining the powerful communication influences on delivering care and health promotion.
The cross-cutting nature of the social determinants of health and clinical and biomedical implications in practice and research settings. This is the prerequisite course to begin the health equity micro-minor.
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:
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”.
This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.
Overview of principles related to leadership, including theories and styles, organizational management and values, communication strategies, and change in the context of healthcare systems.
This course examines the nonclinical, clinical, commercial, regulatory and risk assessment strategies required to develop a clinical development plan for an approvable, marketable new therapeutic and propose life cycle management strategies.
The Clinical Research Industry integrates project management principles, decision-making models, cross cultural competency, and interdisciplinary team dynamics to facilitate effective and efficient conduct of clinical trials.
This course explores how to manage risk and safety assessments to ensure quality in clinical research.
Key stakeholder roles, responsibilities, and processes associated with monitoring, auditing, and oversight in clinical trial conduct.
Overview of business principles related to health care systems and leadership, focusing on strategic management of health care service delivery in various settings. Credit cannot be earned for this course and HSCI 6241.
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 integrate many of the learnings from the CRA program coursework to create a Masters level proposal intended to address a major area of a change, as well as how to implement the change management proposal, within the clinical research industry. Students initially evaluate and develop strategic alternatives through case studies prior to drafting the Master’s proposal.
MSHS Electives (Select One)
Analysis of the strategies and methods of clinical research in international settings; explore cultural and ethical consideration in global clinical research projects.
Foundations of regulatory affairs, including U.S. and international legislation and regulatory processes guidelines. Roles of leaders of regulatory affairs in developing products, navigating the regulatory review and approval process, and contributing to keeping products on the market.
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