CLNR 324 – Experimental Design & Biostatistics
Credit: 4 Hours
The application of statistical analyses to the design, conduct, and interpretation of pharmaceutical research, development, testing, and manufacturing is provided in this comprehensive course.
CLNR 326 – Principles of Clinical Biochemistry
Credit: 2 Hours
Concepts in basic Biochemistry will be covered. Emphasis will be placed on the following topics: 1) structure, function, and their relationship: 2) proteins: 3) enzymes; 4) metabolism: and 5) biological information flow.
CLNR 328 – Introduction to Pharmacology
Credit: 4 Hours
The basic principles of pharmacology and toxicology are covered through discussion of the responses of biological systems to drugs and chemicals. The course also considers the absorption, distribution, metabolism, and excretion of xenobiotics and how these factors relate to drug action. Prerequisite: BIOL 221.
CLNR 330/430 – Regulatory Affairs I & II
Credit: 2 Hours Each
These introductory courses provide the student with an overview of the regulatory requirements and the underlying principles for gaining approval of worldwide marketing applications. Students may be assigned to groups in order to develop an understanding of the teamwork necessary to effectively function in the regulatory process. Information on late phase clinical investigations, subsequent to IND filing, marketing considerations, and periodic safety reporting will be presented. Student groups will be expected to make presentations, which will include the incorporation of a variety of realistic issues and unexpected developments that arise during the review of their applications. Prerequisites: CLNR 463 and 464.
CLNR 334/336 – Scientific Literature Seminar I & II
Credit: 1 Hour Each
Students are introduced to literature searching and critical analysis techniques in this series of courses. The courses promote the formulation of critical thinking approaches. Special emphasis is placed on communication techniques.
Students apply their knowledge and skill in the form of written and oral presentations developed by researching the current pharmaceutical and biomedical literature. Prerequisite: CLNR 451.
CLNR 363 – New Product Development
Credit: 1.5 Hours
This introductory course provides an overview of the broad field of new product development. While primarily designed to give students the basic knowledge required for subsequent courses in clinical research, it will also support the students’ consideration of subsequent career choices. The course will cover the process of development from early research, discovery, and product formulation, through the requirements for proving safety and efficacy. Marketing and promotional considerations necessary for the successful introduction of a product into the marketplace will be discussed, as will the external influences that may alter the development process in the global market place of the twenty-first century.
CLNR 364 – Principles of Clinical Research
Credit: 1.5 Hours
This introductory 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 trials, clinical trial design, clinical trial conduct, and safety surveillance. Application of clinical trial knowledge to specific medical practice issues will also be explored.
CLNR 365/465 – Managing & Monitoring Clinical Trials I & II
Credit: 2 Hours Each
These introductory courses are designed to provide a theoretical and practical overview of the principles of managing and monitoring clinical trials. The multiple practice environments in which clinical research is conducted will be described and the various roles of involved personnel will be discussed Managing & Monitoring Clinical Trials will introduce students to the elements of clinical trial protocols and data collection strategies (e.g. case report forms), and will provide an overview of regulations relevant to clinical trials including responsibilities of sponsors, investigators, institutional review boards, and contract research organizations. In addition, the course will cover selection of investigators, conduct of investigator meetings, site monitoring visits (for study initiation, periodic monitoring, and study termination), patient enrollment issues, safety monitoring, case report form review, and data management. Students will become familiar with Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), the quality assurance process (QA), and FDA audits. Prerequisites: CLNR 463 and 464.
CLNR 379/379L – Physical & Clinical Assessment & Lab
Credit: 2 Hours
This course is designed to introduce students to the basic principles and techniques of history taking and physical and clinical assessment. Students in this course have an opportunity to develop the basic skills necessary to understand lab values and assessment parameters. Prerequisite: BIOL 221
CLNR 416 – Senior Seminar
Credit: 1 Hour
Senior Seminar provides a forum through which students chronicle their B.S. internship experience. Students present an overview of the clinical site at which they worked and provide a synopsis of their role in the organization. Students present findings from their internship to the faculty and other students. Co-requisite: CLNR 420.
CLNR 420 – Senior Internship
Credit: 14 Hours
The full-time internship provides practical experience at one or more clinical research sites. Students and participating institutions are matched to provide a comprehensive work experience. Prerequisite: Completion of all BSCR courses and at least a 2.0 major and cumulative GPA. Co-requisite: CLNR 416.
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 adverse drug experiences, drugs and disease states, and standardized terminology are also considered. Prerequisites: CLNR 463 and 464.
CLNR 451 – Scientific & Technical Writing
Credit: 1.5 Hours
This required course is presented to assist students in skill enhancement in the areas of scientific and technical writing.
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.