Clinical Research Minor

The Clinical Research Program offers a Minor in Clinical Research which focuses on fundamentals of clinical research methods, regulatory considerations, operational steps and clinical background involved in phases one through four of biopharmaceutical product development. Particular attention is directed to study design, interpretation of research findings, and scientific writing. Working in the field of clinical research involves a team approach with several unique roles combined with the responsibility to work across disciplines to participate in the science and business of developing drugs, biologics, and biomedical devices. The program content is relevant to employment in pharmaceutical companies, contract research organizations, clinical research service providers, and clinical settings enrolling clinical trial subjects. The minor will allow students gaining expertise in other areas (e.g., statistics, business, science writing, chemistry, operations management, etc.) to master the fundamental aspects of clinical research and strengthen scientific writing ability, particularly as it describes clinical research.

The Clinical Research Minor is not a nursing or laboratory based program.

Program Objectives for the Minor in Clinical Research

Upon completion of the Minor students should be able to:

Demonstrate a foundational understanding of clinical research methodologies described in study protocols with emphasis on study design, operational aspects, and regulatory compliance.
Interpret statistical results from the published studies in the peer reviewed literature and clinical study reports.
Write scientifically and demonstrate competency in oral presentations involving scientific content.
Apply knowledge and skills gained in the basic sciences to the planning, implementation,and evaluation of clinical research.
Identify sources for regulations, guidance and best practices commonly used in the conduct of clinical trials and post marketing studies in the U.S. and abroad.

Requirements for a Minor in Clinical Research

Core Courses
Completion of a Minor in Clinical Research requires the following core courses (18 credits)
CLR 301 - Introduction to Clinical Research
CLR 310 - Scientific Writing
CLR 330 - Fundamentals of Product Development
CLR 350 - Understanding Medical Terminology and Clinical Endpoints
CLR 410 - Advanced Scientific Writing
CLR 440 - Bioanalytics
An application to complete the minor is not required.

Prerequisite Courses

The following prerequisites are required (8 credits)

Total: 18 core credit hours, 8 collateral (prerequisite) credit hours

Additional Information

A ‘C’ (2.00) or better average is required in all courses counted toward the minor.