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.

This course is intended to provide students with the basic knowledge of descriptive statistics, probability theory, hypothesis testing, and other selected statistical methods including parametric and non-parametric tests for differences in central tendency, paired comparisons, simple linear regression and one-way analysis of variance. Also discussed is the importance of appropriate statistical design in the development of experimental protocols.

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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.

This course provides an introductory overview of the global regulatory requirements for clinical research involving investigational drugs and/or devices. Students will gain an understanding of the need for regulation and have an opportunity to examine historical events, which may provide a preview for future worldwide requirements. Emphasis is placed on pre-clinical and early phase clinical investigations conducted under the requirements of Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs). The Prerequisites for this course are CLNR 363 and CLNR 364.

Students are introduced to literature searching and critical analysis techniques. This course promotes 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.

This course provides an overview of the broad field of new drug 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 drug 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 drug development process in the global market place of the twenty-first century.

This course will begin by defining clinical research and explaining why it is conducted. It will then progress to describe the different environments in which clinical research is conducted, the various research approaches that are used, and the ways in which research results are applied. The course will also describe how clinical research is used to evaluate strategies in medical practice, and how new drugs, devices, biologics, and potential environmental toxins are studied. In addition to discussing patient confidentiality issues, consideration will be given to the impact of politics and advocacy on research priorities and to evolutionary trends in the pharmaceutical, biologic and device industry. The prerequisite for this course is CLNR 362.

This course is the first in a two-semester sequence designed to provide a theoretical and practical overview of the principles of managing and monitoring clinical trials. The purpose of this course is to provide students with a comprehensive understanding of clinical trial methodology in order to prepare them for a career in clinical research. The multiple practice environments in which clinical research is conducted will be described and the various roles of involved personnel will be discussed. This course will cover clinical protocols and data collection strategies (e.g. case report forms), and an overview of regulations relevant to clinical trials including responsibilities of sponsors, investigators, institutional review boards (IRBs), and contract research organizations. In addition, students will become familiar with Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), the quality assurance process (QA), and FDA audits. Prerequisites for this course are CLNR 363 and CLNR 364.

This course is designed to introduce students to the basic principles and techniques of history taking and physical examination. Students in this course have an opportunity to develop the skills necessary to adequately follow the patient using physical assessment parameters and to monitor drug therapy when appropriate.

Senior Seminar provides a forum through which students chronicle their internship experience. Students present an overview of the clinical site at which they worked and provide a synopsis of their role in the organization. The student will present his/her findings from the internship to the faculty and students.

The internship provides practical experience at one or more clinical research sites. Students and participating institutions are matched to provide a comprehensive work experience.

Skills such as negotiation, written and verbal communication, managing meetings, facilitation, influencing without authority, and assertiveness are often key determinants of success in the workplace. In order to teach students how to be more effective in their careers, students will be coached and evaluated on their ability to plan, conduct and/or facilitate meetings, generate effective communications, and foster effective listening, assertion, and influencing skills. Strategies that are successful during conflictive encounters will be stressed. In addition, students will be exposed to effective techniques used in the selection, mentoring, and management of employees including gender and cultural differences. The prerequisites for this course are CLNR 362 and CLNR 453.

This 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.

The roles and responsibilities involved in scientific and technical writing are discussed in terms of types of reports and other documents that will be encountered. Examples from relevant practice settings are reviewed in class and practical exercises presented with opportunities for developing and critiquing assignments.