Skip to content

BSHS in Clinical Research Administration / MSHS in Regulatory Affairs: Curriculum

Curriculum Details

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 Regulatory Affairs. 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 one elective course.

BSHS Core

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 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.

Incorporates economic theory and policy analysis methodology to analyze the impact of changes in the health care system on the practice of health sciences professionals and the quality and process of health care. Development of critical thinking skills through review of current medical literature.

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.

n/a

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.

The goal of the course is to equip learners to examine issues in health care and develop multi-dimensional approaches and solutions.

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.

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.

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.

This is an upper division course intended to introduce students to the legal structures, rules, and mechanisms important to health care professionals, executives and organizations. Students analyze a range of legal standards related to medical malpractice and liability, fraud and abuse, and health care compliance. Since this is a health sciences course, trends in genetics, pharmacy law, and laboratory law will be discussed. In addition, students will become familiar with key legal terms, documents, and sources of law; the tools of communication and governance that shape health care arrangements and practices.

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.

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.

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.

The 9 graduate credits students take in lieu of undergraduate electives are:

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.

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.

Analysis of key contemporary issues in U.S. health and social policy that affect the design and structure of the health care system. The health policy process and initiatives that shape care delivery.

MSHS Core

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.

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.

Covers the development and evaluation of global regulatory strategies that support drug and biologic product development In this course students analyze the critical elements of the product life cycle in the determination of a regulatory strategy, assess the roles of non-clinical and clinical data in determining regulatory strategy, appraise approaches for integrating strategic business needs into regulatory planning and evaluate the role of post-marketing efforts in shaping regulatory strategy.

Provides a framework for the development and evaluation of the regulatory affairs strategies that support device and diagnostics development Objectives for this course are to analyze and evaluate the principle components of global regulatory strategy for devices and diagnostics, examine the regulation of medical devices through an epidemiological lens and analyze essential considerations associated with specific classifications or specialty areas of medical devices.

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 trials 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.

This course focuses on the analysis and evaluation of regulatory affairs compliance strategies and guidelines. Topics include pre- and post-marketing compliance, labeling, advertising and required reporting In this course we identify and assess regulatory requirements, policies and guidelines associated with good practice (GXP) regulatory compliance issues. Students are required to critically analyze regulatory compliance issues and to integrate and develop implementation strategies for ensuring regulatory affairs compliance in medical product manufacturing, development, labeling and marketing. Students will need to demonstrate their ability to craft written regulatory communications including root cause analysis and corrective and preventive actions (CAPAs).

Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. This is a capstone course focusing on the concept of leading change within the contexts of health professionals, health systems and health policy. Organizational, management and change theories, as well as characteristics of personal and professional change leadership, are explored in relation to expectations for successful executive leadership and performance in today’s dynamic health care environments.

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.

ELECTIVES

Issues of health care economics, financial management, and budgeting that relate to managerial decision-making. Applied financial management, management control systems, budgeting, staffing, and cost accounting

This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.

Analysis of the strategies and methods of clinical research in international settings; explore cultural and ethical consideration in global clinical research projects.

This course explores how to manage risk and safety assessments to ensure quality in clinical research.

Covers the analysis of quality and patient safety challenges in U.S. health care with a focus on political and environmental influences.

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 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.

Request more information

Whether you’re curious about a specific program or the day-to-day requirements of learning online, we’re here to answer your questions. Fill out the form and we’ll be in touch.