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 Clinical Research Administration (CRA). Undergraduate and graduate degrees will be conferred sequentially, with the BSHS awarded upon completion of 120 credits (nine 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 in up to 60 credits to satisfy general education and advanced standing requirements. Non-tradtional 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.
General Education and Advanced Standing (60 credits)*
- English Compostion (3 credits)
- Physical or Natural Science with Lab (4 credits)
- Social Sciences (6 credits)
- Humanities (3 credits)
- Advanced Standing: Other academic coursework (44 credits)
*Applicants missing one or more general education courses may be considered for admission, if they have junior standing (i.e. 60 college credits).
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 documentation 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 3117: Principles of Biostatistics 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 (6 credits)
- HSCI 6223: Topics in Health Care Leadership*
- HSCI 6240: Issues and Trends in Health Systems*
Clinical Research Administration Graduate Courses (3 credits)
- CRA 6201: Critical Analysis in Clinical Research*
MSHS in Clinical Research Administration
The MSHS in Clinical Research Administration requires successful completion of an additional 27 credit hours of graduate coursework, including 6 credit hours in research.
Graduate Research Courses (6 credits)
- HSCI 6263: Biostatistics in Clinical and Translational Research
- HSCI 6264: Epidemiology in Clinical and Translational Research
Strategic Leadership Courses (6 credits)
- HSCI 6241: The Health Care Enterprise
- CRA 6275: Leadership and Change in Clinical Research Administration
Clinical Research Administration Core Graduate Courses (12 credits)
- CRA 6202: Medicines Development
- CRA 6203: Partnerships with Human Subjects
- CRA 6204: The Clinical Research Industry
- CRA 6209: Quality and Risk Management
Elective Course (3 credits). Choose one.
- CRA 6208: International Clinical Research
- CRA 6211: Monitoring, Auditing and Oversight in Clinical Research
*Course is taken as an undergraduate and applied to both the BSHS and MSHS curriculum.