BSHS in Clinical Research Administration: Curriculum

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. Laboratory fee. Restricted to medical informatics program majors.

Introduction to the field of regulatory affairs to regulations, strategies, and laws that apply to safe and effective product development.

In addition to the 17 core courses, students will need to take 3-15 elective Health Science courses (9-45 credit hours) depending on how many hours they need to fulfill the graduation requirements. Students may choose their electives from among the health sciences undergraduate courses.