Courses

BS in Clinical Research

Courses

CLNR 101 - Introduction to Clinical Research
Credit: 1 Hour
This course is designed to provide a broad understanding of clinical research and a basic overview of the clinical research industry. The course provides students with a basic understanding of key clinical research topics allowing students a foundation to continue their pursuit of a degree in clinical research and a career in the clinical research industry.

CLNR 324 – Introduction to Biostatistics
Credit: 3 Hours
Statistical methods in health sciences. The course is intended to provide the student with basic knowledge of descriptive statistics, graphing data, probability theory, normal and other common distributions, sampling and estimation, hypothesis testing, ANOVA and other selected statistical methods.

CLNR 326 – Principles of Clinical Biochemistry
Credit: 3 Hours
This course discusses the basic biochemical principles of quantitative analysis utilized in common clinical laboratory tests. An introduction to interpretation of abnormal clinical laboratory values is presented. Quantitative aspects of nutrition are presented, and regulatory effects of various hormones are described.
Prerequisite: CHEM 227 & 228

CLNR 328 – Introduction to Pharmacology
Credit: 4 Hours
The basic principles of drug action are covered through discussion of the responses of biological systems to drugs and chemicals. Emphasis is place on understanding mechanism of action through detailed exploration of receptor-mediated events (pharmacodynamics). The course considers the quantification of drug action as well as the absorption, distribution, metabolism, and elimination of xenobiotics (pharmacokinetics) and how these and other factors relate to drug action.
Prerequisite: BIOL 221 

CLNR 330 – Regulatory Affairs I
Credit: 2 Hours
This course provides the student with an overview of the regulatory affairs universe, with emphasis on requirements for initiating clinical trials, developing pharmaceutical products, and gaining approval for worldwide marketing applications. This is the first of two required regulatory affairs courses in the BSCR program.

CLNR 334 – Scientific Literature Seminar I
Credit: 1 Hour
This course is the first in a two-part series. The skills developed in this class will be further refined in CLNR 336. This interactive class introduces students to literature searching and critical analysis techniques. Skills in critical analysis of the scientific literature will be developed in small group discussion of scientific papers chosen by the faculty and students. These skills are applied in the form of written and oral presentations of projects developed by researching the current biomedical and pharmaceutical literature.
Prerequisite: CLNR 451

CLNR 336 - Scientific Literature Seminar II
Credit: 1 Hour
This interactive class is a continuation of CLNR 334, Scientific Literature Seminar I. The class focus is on the continued application of skills relating to literature searching and critical analysis techniques, skills that were introduced in CLNR 334. These skills are applied in the form of two solo oral presentations. For the first presentation, students will prepare a brief presentation on a scientific research paper of their own choosing, and use PowerPoint to make visual aids to supplement their presentation. The second will be a seminar-style presentation on a health-related topic, again using PowerPoint to generate slides as visual aids.

CLNR 341 – Medical Terminology
Credit: 1 Hour
This course is designed to introduce students to the language of the clinical research and medical communities. Instruction will engage students and provide them an opportunity to learn, understand, and apply the terminology in context of clinical research and medical settings.

CLNR 363 – New Product Development
Credit: 2 Hours
New Product Development provides an introductory overview of the process of developing a molecule into a therapeutic agent. This course provides an overview of the process from discovery through regulatory approval and introduction to the market place. This course will provide a perspective of the interaction required between Research & Development and marketing in order to insure product success in a regulated environment. It is designed to provide students with the background necessary to pursue a wide range of additional courses leading to degrees in clinical research.

CLNR 364 – Principles of Clinical Research
Credit: 2 Hours
This course will provide a broad understanding of clinical research-definition, methodology, conduct and applications. The course will explore basic elements of clinical research including the hierarchy of clinical design, clinical trial conduct, and safety surveillance. Application of clinical trial knowledge to specific medical practice issues will also be explored.

CLNR 365– Managing & Monitoring Clinical Trials I
Credit: 2 Hours 
This introductory course has been designed to provide both a theoretical and practical overview of the principles of managing and monitoring clinical trials. Lectures will focus on the practical aspects of study set-up activities (i.e., study planning issues, data collection strategies, selecting investigators), study conduct activities (i.e., subject recruitment issues and enrollment strategies, obtaining informed consent, monitoring both patient and safety data quality and integrity and conducting site visits for study initiation, periodic monitoring and multiple site closings), and study termination activities. The course also covers responsibilities of sponsors, clinical monitors, clinical research organizations, investigators and institutional review boards. In-class activities will allow students to gain a greater appreciation of operational issues associated with various clinical research-related regulatory documents by working with case studies related to the content studied. Lectures are based on U.S. regulations and guidelines, as well as international good clinical practices and significant clinical research-related documents.
Prerequisites: CLNR 363 & 364

CLNR 379/379L – Physical & Clinical Assessment & Lab
Credit: 2 Hours
This course is designed to introduce students to the basic principles of medical terminology, history taking, the basic techniques of physical examination assessment, and diagnostic test data.
Prerequisite: BIOL 221

CLNR 416 – Senior Seminar
Credit: 1 Hour
This course is designed to prepare the student for real world practices. The student will learn and review research, presentation and public speaking techniques and utilize these to prepare a research paper and presentation. This course culminates in a presentation day where each student will present their research information and internship experience to the Department of Clinical Research and honored guests.
Co-requisite: CLNR 420

CLNR 420 – Senior Internship
Credit: 14 Hours
This course is an experiential learning system, which allows the BSCR students an opportunity to gain hands on experience in the clinical research profession. Students and participating institutions are matched to provide a comprehensive work experience.  The internship is designed for a BSCR candidate to develop strong clinical research skills while improving his/her knowledge in the field of clinical research.
Prerequisite: Completion of all BSCR courses and at least a 2.0 major and cumulative GPA.
Co-requisite: CLNR 416

CLNR 440 – Regulatory Affairs II
Credit: 2 Hours
This course builds upon concepts developed in Regulatory Affairs I and provides more detailed and broader coverage of the terminology and concepts that address the regulation of the pharmaceutical industry by the Food and Drug Administration, with an emphasis on the drug, biologic and veterinary product development and approval process.
Prerequisites: CLNR 363, 364 & 330

CLNR 442 – Interpersonal Skills
Credit: 2 Hours
In this course, students will learn about the various factors involved in developing good interpersonal speaking and writing skills including: self-awareness, understanding individual differences, goal setting, listening and feedback, teamwork, leadership development and motivating others, delegation, negotiation, conflict resolution, interviewing, and presentation skills. The course will provide a forum for group discussions and writing exercises.

CLNR 450 – Data Management
Credit: 2 Hours
This introductory course covers topics such as the role of data management in clinical trials and the duties of the
Clinical Data Coordinator. Topics include organization, collection, review, and tracking of data. Coding of data and standardized terminology are also considered.
Prerequisites: CLNR 363 & 364

CLNR 451 – Scientific & Technical Writing
Credit: 1.5 Hours
Scientific and Technical Writing is a required course for Clinical research majors designed to enable students to effectively and accurately write a variety of technical documents used in pharmaceutical-related industries.  

CLNR 465 – Managing & Monitoring Clinical Trials II
Credit: 2 Hours
This course will continue to build upon concepts introduced and developed in the Managing and Monitoring Clinical Trials I class. Additional material will be added as appropriate, and the students will be given a greater depth of knowledge and understanding about topics covered in the first course.
Prerequisites: CLNR 363, 364, 365 & 450

CLNR 474 – Biopharmaceutics
Credit: 3 Hours
This course presents the biological and physiochemical factors of the body, drugs and dosage forms that influence drug availability, disposition, and pharmacological and toxicological responses.
This course is co-listed as PHAR 314.
Permission of instructor required.