The Secondary Field of Study (SFS) is intended to provide current GW undergraduates knowledge within the field of Clinical Research Administration (CRA), including an understanding of the different phases of drug and device development, basic terminology in the field, the key stakeholder roles and their responsibilities, good clinical practice, and principle components of clinical research trials for drugs, devices, and combination products.
This SFS offers GW students an opportunity for an additional concentration related to their area of study. Previous experience in health care is not required. While the program can offer a unique insight into health care for all majors, the SFS is particularly useful for those students interested in public policy, business, and biomedical engineering. Students in the public policy realm will explore healthcare policies that shape current healthcare practice and delivery. Business students can apply basic project management principles and business practices to facilitate quality clinical research activity. Biomedical engineering students will develop a general foundation in clinical trial conduct practices for developing new drugs and devices.
The Secondary Field of Study requires successful completion of 15 credit hours:
Foundation Courses (12 credit hours)
CRA 2101: The 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.
HSCI 2105: Current Issues in Bioethics
Elective (3 credit hours; chosen with academic advisor)
CRA 2104: 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.
HSCI 2103: Health Policy and the Health Care System
Signature on Required Forms
Obtain required form(s) from home school. Contact Becky Karlin for signature.
2100 Pennsylvania Ave, NW
Washington, DC 20037