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 (CRA) and the Master of Science in Health Sciences (MSHS) in Regulatory Affairs (RAFF). Undergraduate and graduate degrees will be conferred sequentially, with the BSHS awarded upon completion of 120 credits (9 of which are taken for graduate credit). The MSHS is awarded following completion of an additional 27 credits of graduate coursework.
BSHS in Clinical Research Administration
The BSHS with a major in Clinical Research Administration is a degree completion program that requires successful completion of 120 credit hours. Students may transfer 45 to 60 credits to satisfy general education and advanced standing requirements. Non-traditional credit sources may be considered on a case-by-case basis (i.e. military coursework, credit-by-exam, and non-college based health programs). Students must complete at least 60 credit hours of GW coursework to meet the academic residency requirements for the program.
Transfer Credit Policy
For an assessment on the transferability of your previous coursework, please contact the program office. Coursework will be evaluated for transfer using the following criteria:
- Academic in nature
- Completed at a regionally accredited institution
- Earned with a C or better (C- grades do not transfer)
A limited amount of non-traditional credit sources may be considered on a case-by-case basis. Appropriate documention required. Please contact the program office for more information.
Coursework at GW (60 credit hours; 3 credits each)
Health Sciences Distance Education Courses (51 credits)
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.
- HSCI 2102: Pathophysiology
- HSCI 2103: Health Policy and the Health Care System
- HSCI 2105: Current Issues in Bioethics
- HSCI 2107: Health Care in Literature
- HSCI 2112W: Writing in the Health Sciences
- HSCI 2113: Informatics in the Health Sciences
- HSCI 2117: Introduction to Statistics for Health Sciences
- HSCI 4103: Health Care Law & Regulation
- HSCI 4105: Case Studies in Health Care
- HSCI 4106: Introduction to Epidemiology
- HSCI 4112W: Research and Writing for Health Sciences
Graduate Strategic Leadership Courses
- HSCI 6223: Topics in Health Care Leadership*
- HSCI 6240: Issues and Trends in Health Systems*
Regulatory Affairs Field
- RAFF 6201: Introduction to Global Regulatory Affairs*
MSHS in Regulatory Affairs
The MSHS in Regulatory Affairs requires successful completion of an additional 27 credit hours of graduate coursework, including 6 credit hours in research.
Regulatory Affairs Courses (15 credits)
- RAFF 6202: Regulatory Strategy in the Development of Drugs and Biologics
- RAFF 6203: Regulatory Strategy in the Development of Devices and Diagnostics
- RAFF 6204: Integration of Regulatory Science
- RAFF 6205: Regulatory Compliance
- RAFF 6275: Leadership and Change in Regulatory Affairs
Graduate Research Courses (6 credits)
- HSCI 6263: Biostatistics for Clinical & Translational Research
- HSCI 6264: Epidemiology for Clinical & Translational Research
Foundation in Health Science Course (3 credits)
- HSCI 6241: The Health Care Enterprise
Elective Course (3 credits; choose one)
- CML 6274: Health Economics and Finance
- CRA 6203: Partnerships with Human Subjects
- CRA 6208: International Clinical Research
- CRA 6209: Monitoring Clinical Research
- CRA 6210: Medical Writing in Clinical Research
- HCQ 6201: Building a Quality Culture
- HSCI 2101: Psychosocial Aspects of Health and Illness
- HSCI 3117: Biostatistics for Health Sciences
- HSCI 6223: Topics in Health Care Leadership
- HSCI 6264: Epidemiology for Clinical and Translational Research (Recommended)
*Course is taken as an undergraduate and applied to both the BSHS and MSHS curriculum.