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. 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, chemistry, biology, etc.) to master the fundamental aspects of clinical research for careers in the clinical research industry or conducting clinical research as a clinician.

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: Discuss the foundational elements of clinical research methodologies described in study protocols with emphasis on study design, ethical aspects, operational aspects, and regulatory compliance. Explain scientific and regulatory concepts related to the development, design, and analysis of clinical studies for biopharmaceutical and medical device product development. Discuss clinical study operations in the context of Good Clinical Practice and other relevant guidelines and regulations Describe the collection, flow, and management of data through a clinical study and the role of statistics and informatics. The Clinical Research minor is not a nursing or laboratory-based program.

Requirements for a minor in Clinical Research

Completion of a minor in Clinical Research requires 12-18 credit hours from the following core courses and up to 6 credit hours from the electives specified below. An application to the minor is not required.

Core Courses (12-18 credit hours):

CLR 301 - Introduction to Clinical Research Credit Hours: 3
At least three of the following Core Courses:
CLR 325 - Pharmacotherapeutics Credit Hours: 3
CLR 330 - Fundamentals of Biopharmaceutical Product Development Credit Hours: 3
CLR 340 - Study and Site Management for Clinical Trials Credit Hours: 3
CLR 350 - Understanding Medical Terminology and Clinical Endpoints Credit Hours: 3
CLR 430 - Managing and Monitoring Clinical Trials Credit Hours: 3
CLR 440 - Bioanalytics Credit Hours: 3
CLR 450 - Data Management Credit Hours: 4

Electives (up to 6 credit hours):

Up to 6 credit hours from any of the following courses can be applied, but are not required if additional CLR courses are taken:

BIO 308 - Biology of Cancer Credit Hours: 3
BIO 370 - Evolutionary Medicine Credit Hours: 3
CHM 211 - Organic Chemistry I Credit Hours: 3
CHM 235 - Quantitative Analysis Credit Hours: 3
CSC 231 - Introduction to Data Structures Credit Hours: 4
CSC 385 - Professional and Ethical Issues in Computing Credit Hours: 3
ENG 312 - Writing Strategies for Business and Innovation Credit Hours: 3
ENG 313 - Writing About Science, Medicine, and the Environment Credit Hours: 3
EXS 310 - Research Methods in Exercise Science Credit Hours: 3
EXS 320 - Exercise Physiology Credit Hours: 3
MGT 350 - Principles of Management Credit Hours: 3
MKT 340 - Principles of Marketing Credit Hours: 3
PBH 310 - Social and Behavioral Determinants of Health Credit Hours: 3
PBH 320 - Foundations of Global Health Credit Hours: 3
PBH 452 - Epidemiology Credit Hours: 3
PSY 245 - Drugs and Behavior Credit Hours: 3
PSY 256 - Brain and Behavior Credit Hours: 3
PSY 355 - Introduction to Experimental Psychology Credit Hours: 6
SCM 370 - Principles of Operations Management Credit Hours: 3
STT 215 - Introduction to Statistics Credit Hours: 3
STT 315 - Probability and Statistics Credit Hours: 3
Complete one of the following sequences:
BIO 240 - Human Anatomy and Physiology I Credit Hours: 3
BIO 241 - Human Anatomy and Physiology II Credit Hours: 3
or
EXS 216 - Human Anatomy and Physiology I Credit Hours: 3
EXS 217 - Human Anatomy and Physiology II Credit Hours: 3
Some non-CLR courses require pre-requisites. Students are expected to complete the prerequisites outside the CLR minor.

Total: 18-19 total credit hours

Additional Information

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