The objective of the major is to prepare students for distinguished careers in clinical research. Graduates of this program are expected to play a wide variety of roles in the clinical research and the drug development process. Clinical research has emerged as a multidisciplinary enterprise that requires a highly trained team of scientists and clinical investigators serving a variety of functions. This novel program, developed through the efforts of the School of Pharmacy faculty, adjunct faculty, and corporate partners provides BS students with the didactic and experiential training necessary for the development of diverse careers (these specific roles are listed in the next sentence) as clinical researchers in contract research organizations (CROs), pharmaceutical companies, government agencies or academia. The growing demand for high-quality clinical monitors and study coordinators suggests that students from this program will receive excellent employment opportunities immediately following graduation.

Candidates for the BS degree with a major in clinical research must complete a minimum of 49 hours in pharmaceutical sciences and clinical research courses which include PHSC 210, 220, 323/325, 324, 328, 334, 336 and 451, CLNR 362, 416, 420, 442, 450, 453, 458, 479, 530, and 558. In addition, students must also complete the General College Curriculum, including Math 111 or 122 and RELG 348, and the following ancillary courses: BIOL 111, 201, 221 and 334, CHEM 111, 113, 227 and 228.

RELG 348 Medical Ethics (3)
This course is a study of medical ethics from a Judeo-Christian perspective. The first part of the course examines approaches to making ethical decisions and various philosophies of medical ethics. Part two analyzes specific issues relating to birth and death. The third part investigates pharmaceutical ethics and issues related to clinical research.

362 New Drug Development (1.5)
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.

410 Pharmacokinetics (2)
This course is designed to provide the student with an understanding of basic, clinically applicable pharmacokinetic formulas and the assumptions that are involved with their use in therapeutic drug monitoring. This course is co-listed as PHAR 410. Prerequisite: Permission of instructor.

416 Senior Seminar (1)
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. Prerequisite: CLNR 420.

420 Senior Internship (14)
The internship provides practical experience at one or more clinical research sites. Students and participating institutions are matched to provide a comprehensive work experience. Prerequisite: CLNR 558 or permission of instructor.

442 Interpersonal Skills (2)
In this course, students will learn about the various factors involved in developing good interpersonal 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. This course will provide a forum for group discussions and team exercises.

450 Data Management (2)
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.

PHSC 451 Scientific & Technical Writing (1)
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.

453 Introduction to Clinical Research (1.5)
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 trials, clinical trial design, clinical trial conduct, and safety surveillance. Application of clinical trial knowledge to specific medical practice issues will also be explored.

458 Managing & Monitoring Clinical Trials I (2)
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 362 and CLNR 453.

462 Preclinical Drug Development (2)
This course provides students with an overview of the process of classical and modern drug development. The course will also provide a perspective of the interaction of research, development and marketing activities in a regulated environment. Particular emphasis is placed on promising approaches expected to lead to novel therapies and drug delivery systems within the next decade. A focus on illustrating future therapeutic targets and drug delivery systems is included. Prerequisite: CLNR 362.

474 Biopharmaceutics (3)
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. Prerequisite: Permission of instructor.

479 Physical & Clinical Assessment (2)
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. Prerequisite: Anatomy and Physiology.

504 Special Research in Clinical Research (1 to 3)
The purpose of this elective course is to introduce the pharmacy student to methods of basic science and/or clinical research. This involves application of the scientific processes of hypothesis formation, literature evaluation, experimental design, development of teaching skills, data acquisition and analysis, and formal presentation of results.