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

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 in up 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:

  • College-level
  • 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)
 CRA 2101: Basics of Clinical Research

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.

 CRA 2102: Processes of Clinical Research

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.

 CRA 2103: Good Clinical Practices

The student analyzes the rationale and goals of Good Clinical Practice (GCP), and applies key principles within the context of case studies.

 CRA 2104: The Business of Clinical Research

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.

CRA 2105: Capstone in Clinical Research Administration

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.

CRA 2107: Introduction to Monitoring Clinical Trials

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
  • 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 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.