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Clinical Research

Clinical Research | Clinical Research Course Listing

Professors: Dr. Gertz (Chair of Clinical Research)

Associate Professors: Dr. Jamerson, Dr. Sogol, and Dr. Taylor

Assistant Professors: Mr. Schmid

Adjunct Faculty: Dr. Bowes, Dr. Call, Ms. Chew Mr. Costa, Mr. Cowell, Dr. Gray, Dr. Kinney, Mr. Knight, Ms. Knight, Ms. McManus, Dr. Russell, Dr. Segreti, Dr. Sigel

Major in Clinical Research (CIP 51.2006)
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. It is also concerned with investigating the influence of population and biological diversity as well as disease states on responses to treatment. The results of clinical research studies (especially clinical trials) are essential for gaining approval for marketing new medications and devices or new indications of existing products from regulatory agencies throughout the world.

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 research support staff 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 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.

Students declaring a clinical research major must have a 2.5 or higher GPA prior to their junior year.  Candidates for the BS degree with a major in clinical research must complete a minimum of 45.5 hours in clinical research and pharmaceutical sciences courses which include PHSC 323/325, 324, 328, 334, 336 and 451, CLNR 362, 416, 430, 442, 450, 453, 459, 479, and 460. In addition, students must also complete the General College Curriculum, including Math 111 or 122 two Religion courses, and the following ancillary courses: BIOL 111, 201, 221 and 334, CHEM 111, 113, 227 and 228.

Clinical Research Course Listing (CLNR 000)

324 Experimental Design & Biostatistics (4)
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. Course is co-listed as PHSC and PHAR 528.

362 Introduction to New Product 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 studentsí 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.

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. Co-requisite: CLNR 420.

430 Introduction to Regulatory Affairs (3)
This introductory course will provide the student with an overview of the regulatory requirements and the underlying principles for gaining approval of worldwide marketing applications.  Student s 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 362.

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 writing exercises.

450 Introduction to Data Management (2)
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.

453 Introduction to Principles of Clinical Research (1.5)
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.

459 Managing & Monitoring Clinical Trials (3)
This introductory course is 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 collections 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 362 and CLNR 453.

420 Senior Internship (14)
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: CLNR 459 or 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 and clinical assessment. Students in this course have an opportunity to develop the skills necessary to understand lab values and assessment parameters. Prerequisite: Anatomy and Physiology.

 

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