Dual Degree: BSHS in Clinical Research Administration / MSHS in Regulatory Affairs- Curriculum

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. 

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.

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.

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.

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.

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.

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.

Development and evaluation of the regulatory affairs strategies that support drug and biologic development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IND and NDA.

Development and evaluation of the regulatory affairs strategies that support device and diagnostics development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IDE, 510K, PMA.

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.

Analysis and evaluation of regulatory affairs compliance strategies and guidelines. Pre and post marketing compliance of medical products, oversight, labeling, advertising and use.

Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. The development of leadership solutions to problems in leading regulatory strategic change; integration of all field coursework into implementation plans for health care system changes.

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.

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. 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.