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BSHS in Clinical Research Administration: Curriculum

Curriculum Details

60 TOTAL CREDITS REQUIRED

Students must earn a total of 120 college credit hours to receive the BSHS degree. They may transfer up to 60 college credit hours from another institution which are applied toward the general education and advanced standing requirements. Students must earn at least 60 college credit hours at GW to meet the academic residency requirement and fulfill the required courses for the major.

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 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.

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 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.

n/a

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.

Introduction to health care informatics, including management and clinical information systems and their role in administration, clinical, and research arenas in health care.

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.

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.

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

n/a

Includes a significant engagement in writing as a form of critical inquiry and scholarly expression to satisfy the WID requirement.

Elective

Evaluation of major problem areas in the management of health sciences organizations. Discussions include legal, technological, managerial, organizational, and leadership issues in the changing health care environment.

n/a

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.

Analysis of the structures in place to enhance the quality of health care delivery and political and economic influences that affect quality improvement programs. Assessment of specific interventions to enhance health care from the perspectives of providers and patients.

An overview of basic public health concepts for health sciences students, including epidemiology, health promotion, and disease prevention Review of current issues in health promotion Completion of a public health project in a clinical site.

Biostatistics for health science professionals. Concepts and methods, including confidence intervals, ANOVA, multiple and logistic regression, and non-parametric analyses. Scientific literature is used to provide a comprehensive context in which analytical evidence is employed to support practices in the health sciences.

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