Undergraduate Academic Policies
Department and Course Descriptions
Table of Contents
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
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
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
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.