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Clinical Research
Department of Clinical Online Master of Science in Clinical Admission Policies
Research Research (MSCR) The MSCR program is a year round program,
The Master of Science in Clinical Research entirely online, with applicants considered for
Campbell University
degree is an online program. The program fall, spring and summer semesters. While the
College of Pharmacy & Health Sciences
is designed to educate students in literature Department operates on rolling admission,
180 Main Street
evaluation, study design, research individuals should submit their applications
Buies Creek, NC 27506
methodologies, data management, and by the following deadlines:
910-814-5755
statistical analysis and interpretation. The Fall Admission: June 30
online environment offers enhanced Spring Admission: October 31
Mission Statement
interaction between peers, faculty and Summer Admission: March 31
The mission of the Department of Clinical
industry professionals. The MSCR program
Research is to educate and train students
culminates with a research project based on The following requirements and standards
to meet existing and future clinical research
the students’ therapeutic interest. Students are designed to ensure scholastic and
needs; and, to provide leadership to the
may work independently or collaborate with professional success in the College’s MSCR
clinical research industry. The Department
another MSCR student. The faculty serve degree program. Applications for admission
of Clinical Research supports the broad
as research project advisors throughout the to the MSCR degree program are evaluated
mission of Campbell University and the
entire research project experience. This by the Department of Clinical Research’s
College of Pharmacy & Health Sciences.
degree prepares graduates to enter the field admissions committee. Acceptance into the
in positions including data managers, graduate program is based on the overall
Academic Programs medical writers, clinical research record and ability of the applicant.
The Department of Clinical Research offers monitors, study coordinators, regulatory
a Bachelor and Master of Science in Clinical affairs specialists, Institutional Review Board There are three pathways to admissions
Research degrees as well as a minor. The (IRB) administrators and project specialists. to the MSCR program. Applicants may be
Master of Science in Clinical Research In addition, many graduates pursue considered in one of the following categories:
degree is offered as an online program. The professional degrees within the medical and
Clinical Research Program is located forty- health sciences fields. 1. Graduate of a Bachelor’s program
five minutes from North Carolina’s Research These applicants are required to have
Triangle Park, one of the world’s largest and 4+1 Program completed their undergraduate degree,
most dynamic research centers. Many world- The Department of Clinical Research from a regionally accredited college or
class research hospitals and organizations in provides an avenue for students to earn university, prior to matriculation and
this area look to Campbell’s clinical research both their Bachelor of Science and Master of enrollment in any graduate coursework.
graduates when recruiting new talent. Science in Clinical Research degrees. While Individuals may apply prior to completion
the traditional time to earn both degrees is of their undergraduate degree and gain
Bachelor of Science in Clinical six years, the 4+1 program places students acceptance contingent upon completion of
Research (BSCR) on a fast track toward completing two the degree.
The Bachelor of Science in Clinical degrees in five years by utilizing two summer
Research degree is ideally suited to prepare sessions. By virtue of pursuing both degrees, 2. Campbell University undergraduate
students for entry-level jobs in the clinical the program offers students a competitive student pursuing BSCR/MSCR 4+1
research industry. Students in the program edge in the job market and rapid career Qualified applicants may apply to the
are required to complete an internship in the advancement. MSCR program with the understanding
clinical research field, which provides them the students will not have a completed
with networking opportunities, potential jobs, Clinical Research Minor degree prior to enrolling in MS coursework
and experiential training. The department Students pursuing degrees in multiple as defined in the academic bulletin.
collaborates with sites primarily located disciplines will benefit from additional Accepted applicants would complete the
throughout North Carolina and neighboring education in Clinical Research to augment BS and MS degrees in a five year period
states to facilitate their placement. Students their major field of study. These disciplines/ as outlined. Please note: The MS degree
may choose an internship site based programs include: Nursing, Biology, cannot be conferred upon the students
on their future career goals, including Chemistry, Exercise Science, Pre-Med, in this category until the requirements of
academics, clinical settings or research Pre-Law, Healthcare Management, Business bachelor’s degree are met.
management sites. Many BSCR graduates Administration, and Psychology. To complete
gain employment as a direct result of their the Clinical Research minor, students must
internship experience. complete 19.5 credit hours of prescribed
clinical research courses.
www.campbell.edu/cphs 93. PharmD/MSCR dual degree applicant Prerequisites International Students
An applicant with acceptance into the Anatomy & Physiology (must be completed 1. International applicants are eligible
doctor of pharmacy (PharmD) program prior to enrolling in CLNR 519 Physical & for admission if they have completed a
may apply for the MSCR program to Clinical Assessment) bachelor’s degree or higher. International
pursue the PharmD/MSCR dual degree. Statistics (must be completed prior to applicants must have their transcripts
Since matriculants to the PharmD program enrolling in the Biostatistics course evaluated by WES or AACRAO to be
are only required to have completed 64 sequence) considered for admission.
hours of pre-requisites, and not required Science Courses (12 hours including 2 2. This program is completely online with no
to have an undergraduate degree, lab courses must be completed prior to residency required; therefore, international
these MSCR applicants may enter the matriculation) applicants are not eligible to receive US
program with or without completion student visas.
of an undergraduate degree prior to Application Process 3. If English is not the applicant’s native
enrollment. Accepted applicants have 1. Complete application with required $50 language, applicants must submit official
been accepted into both degree programs fee scores for the TOEFL {>100 (internet
and normally pursue the degrees over a 2. Submit all official college transcripts based)} or IELTS (>7.0, with no individual
five year time period. Students without an 3. Submit GRE scores (a written request band score below 6). Applicants who have
undergraduate degree cannot graduate may be made for the consideration of completed their undergraduate degree
with the MSCR until completion of the PCAT/MCAT/LSAT/GMAT scores) and in English in the U.S. are not required to
requirements of a doctor of pharmacy TOEFL/ IELTS scores (if applicable) submit English proficiency test scores.
degree or a bachelor’s degree are met. 4. Submit two professional/academic letters
Refund Policy
of recommendation
It should be noted the Admissions Committee An admissions deposit of $200 is required
5. Qualified applicants will be contacted for
continues to review the results of pending of each accepted applicant. These deposits
an interview
coursework, test scores and behavior during are non-refundable. Additionally, no refunds
*It is strongly recommended the PharmD/
the admissions and matriculation process. are provided for a student, who attends any
MSCR Dual Degree students plan to start
The Admissions Committee reserves the right class and subsequently withdraws, drops
their MSCR curriculum in the Summer Term.
to rescind the offer of admission due to poor any course(s) or are suspended from CPHS
performance or unprofessional behavior. for any cause. Upon matriculation, the
Policies admissions deposit is applied toward the
1. Matriculating students may enroll in MSCR student’s tuition.
Admission Requirements courses before they have completed all
Bachelor’s degree or higher from a program pre-requisites. However, students
regionally accredited college or university must complete pre-requisite coursework
Academic Standards
(Exceptions: BSCR/MSCR 4+1 and specified for any MSCR course prior to
PharmD/MSCR applicants) enrollment as indicated in the BS in Clinical Research
GPA of 3.0 or higher pre-requisite section above. Academic standards for undergraduate
GRE verbal ≥ 50th percentile, quantitative 2. Those who have earned a terminal programs are specified in Campbell
≥ 50th percentile, analytical writing ≥ 3.0 doctoral degree (e.g. PhD, MD, DO, DPT or University’s Undergraduate Academic
(a written request may be made for the PharmD) at a regionally accredited Bulletin.
consideration of PCAT/MCAT/LSAT/GMAT institution in the United States are not
scores) required to submit a GRE or other test MS in Clinical Research
GRE School Code: 4575 scores. Students in the MSCR program are
Department Code: 0626 3. Students requesting a leave of absence subject to:
TOEFL > 100 (internet-based) or IELTS > of greater than one semester must notify 1. Maintain minimum cumulative grade point
7.0, with no individual band score below 6. department chairman in writing. The chair- average of 3.0.
Institution Code: 5100 man will evaluate requests on an individ- 2. All grades of D or F must be repeated and
All required academic coursework must ual basis and determine the length of the receive a grade of C or higher
be completed at a regionally accredited granted leave of absence, not to exceed 3. Failure to maintain any of the above will
college or university. All prerequisite two semesters. result in a probationary period not to
courses must be completed with earned exceed one academic year. In addition,
grades of “C” or higher. Note: A maximum of six credit hours based students must complete an academic
on previous didactic coursework may be contract to acknowledge their academic
requested for exemption or transfer by probation.
submitting the appropriate form (with 4. Student must complete all coursework
supporting documentation) to the Course within five years of entering the program.
Director. Subsequent approval by the
Department Chairman and the Associate
Dean of Academic Affairs is required.
10 2014-2015 Academic BulletinPolicies & Procedures granting the variance. The Associate Dean for Junior Year
A maximum of six credit hours based Academic Affair’s decision is final. Semester 1
on previous didactic coursework may be The MSCR program will not approve a Courses Credit Hours
requested for exemption or transfer by request to participate in Commencement CLNR 326 – Princ. of Clin. Biochem 3
submitting the appropriate form (with Ceremonies unless all credit hours have CLNR 341 – Medical Terminology 1
supporting documentation) to the Course been completed. CLNR 363– New Product Develop. 2
Director. Subsequent approval by the CLNR 364 – Princ. of Clin. Research 2
Department Chairman and the Associate CLNR 324 – Intro. to Biostatistics 3
Dean of Academic Affairs is required. Curriculum CLNR 451 – Sci. & Technical Writing 1.5
Transfer Credit from equivalent UNIV XXX – Social Science Elective 3
coursework may be conditionally granted. BS in Clinical Research Total 15.5
When requesting a transfer, students must
include: Freshman Year Semester 2
Previous course name and graduate level Semester 1 Courses Credit Hours
number Courses Credit Hours CLNR 328 – Intro. to Pharmacology 4
Semester course was taken CHEM 111 – General Chemistry I 4 CLNR 330 – Regulatory Affairs I 2
Educational institution where course was BIOL 111 – Basic Biology 4 CLNR 365 – Managing & Monitoring
taken ENGL 101 – Freshman Comp. I 3 Clin. Trials I 2
Syllabus for the course RELG 125 – Intro. to Christianity 3 CLNR 442 – Interpersonal Skills 2
Transcript with grade for course (in PHAR 100 – Pre-Pharmacy Sem.* 1 CLNR 379 – Physical & Clin.
applicant file at Campbell) CUC 100 – CU Connections 0.5 Assessment 2
Total 15.5 CLNR 334 – Scientific Lit. Seminar I 1
When transferring, the Course Director will ENGL XXX – Literature I 3
make a recommendation regarding possible Semester 2 Total 16
CLINICAL RESEARCH
equivalency directly to the Chairman of the Courses Credit Hours
Department and the Associate Dean for CHEM 113 – General Chemistry II 4 Senior Year
Academic Affairs. Final decisions regarding BIOL 221 – Human A & P 4 Semester 1
course equivalencies will be made jointly MATH 122 – Calculus 4 Courses Credit Hours
by the Chairman of the Department of ENGL 102 – Freshman Comp. II 3 CLNR 465 – Managing & Monitoring
Clinical Research and the Associate Dean PE 185 – Lifetime Wellness 2 Clin. Trials II 2
for Academic Affairs. The total number of CUC 100 – CU Connections 0.5 RELG XXX – Religion 3
transfer credits granted per student will Total 17.5 CLNR 440 – Regulatory Affairs II 2
follow the policies of Campbell University’s
CLNR 450– Data Management 2
College of Pharmacy & Health Sciences and Sophomore Year CLNR 336 – Scientific Lit. Seminar II 1
the Southern Association of Colleges and
Semester 1 ENGL XXX – Literature II 3
Schools Commission on Colleges.
Courses Credit Hours LANG 201 – Intermed. Foreign Lang I 3
CLNR 101 - Intro to Clinical Total 16
Grade Appeals Research** 1
Students in the MSCR program who CHEM 227 – Organic Chemistry I 4 Semester 2
feel they have a just reason for appealing a BIOL XXX – Biology Elective^ 3/4 Courses Credit Hours
grade in a CPHS course must first appeal to PHYS 221 – General Physics I* 4 CLNR 420 – Senior Internship*** 14
the Course Director. If the issue cannot be HIST 111 – Western Civilization I 3 CLNR 416 – Senior Seminar 1
adequately resolved with the director, then PE 111 – Exercise Activity 1 Total 15
the student may appeal to the Department CUC 200 – CU Connections 0.5
of Clinical Research’s Academic Standards Total 15.5-16.5 Total credit hours earned 127.5-129.5
and Student Affairs Committee. If the
student feels the Committee’s decision is Semester 2 *Courses not required for BSCR degree;
unjust, the student can then appeal to the Courses Credit Hours however strongly recommended for pre-
Chair of the Department. If the student CHEM 228 – Organic Chemistry II 4 pharmacy requirements.
feels the Chair’s resolution is not just, the BIOL XXX – Biology Elective^ 3/4
student must then submit a written petition HIST 112 – Western Civilization II 3 **Course is not required for BSCR degree;
to the Associate Dean for Academic Affairs A/M/T 131 – Intro. to Art, Music however, it is recommended.
at CPHS within seven days of the student’s or Theatre 3
receipt of notification of the Chairs decision. ECON XXX– Econ. Elective 3 *** All BSCR students must submit and
The petition must contain the specific CUC 200 – CU Connections 0.5 pass a criminal background check and drug
variance requested and a description of any Total 16.5-17.5 screen. Students must have all necessary
extenuating circumstances intended to justify immunizations in order to be placed on
www.campbell.edu/cphs 11internship. Please refer to the General Semester 3 Semester 7
Information section of the Academic Bulletin Courses Credit Hours Courses Credit Hours
for more specific details. CLNR 101 - Intro. to Clinical CLNR 520 – Data Management 2
Research 1 LANG 201 – Intermed. Foreign
^ Biology electives must be Bio-Medical CHEM 227– Organic Chemistry I 4 Lang. I 3
electives. (Examples include, but are not BIOL XXX – Biology Elective^ 3/4 ENGL 20X – Lit. II 3
limited to, Advanced Physiology, Biomedical PHYS 221 – General Physics I** 4 CLNR 568 – Project Management 2
Ethics, Developmental Anatomy, Cellular HIST 111 – Western Civilization I 3 CLNR 559 – Managing & Monitoring
& Molecular Biology (pre-requisite for PE 111 – Exercise Activity 1 Clinical Trials 3
Microbiology & Immunology) (pre-requisite CUC 200 – CU Connections 0.5 CLNR 566 – Advanced Study Design 3
for Medical Microbiology), Cytology/Histology, Total 16.5-17.5 Total 16
Bioinformatics, Genetics, Immunology,
Advanced Cell & Molecular Biology, and Semester 4 Semester 8
Biochemistry). Courses Credit Hours Courses Credit Hours
CHEM 228 – Organic Chemistry II 4 RELG XXX – Religion 3
NOTE: Please refer to our website at www. BIOL XXX – Biology Elective^ 3/4 CLNR 530 – Regulatory Affairs 3
campbell.edu/cphs for the most up to date HIST 112 – Western Civilization II 3 CLNR 606 – Clinical Research
curriculum information. A/M/T 131 – Intro to Art, Music, Seminar 2
or Theatre 3 CLNR 5XX – Elective 2
4+1 Program ECON XXX – Econ. Elective 3 CLNR 5XX – Elective 2
The Department of Clinical Research CUC 200 – CU Connections 0.5 Total 12
provides an option for students to earn both Total 16.5-17.5
their Bachelor of Science and Master of
Summer 2
Science in Clinical Research degrees. While
Semester 5 Courses Credit Hours
the traditional time to earn both degrees is
Courses Credit Hours CLNR 420 – Senior Internship*** 14
six years, the 4+1 program places students
CLNR 326 – Principles of Clinical CLNR 416 – Senior Seminar 1
on a fast track toward completing two
Biochemistry 3 CLNR 504 - Special Research in CR 2
degrees in five years by utilizing two summer
CLNR 341 – Medical Terminology 1 Total 17
sessions. By virtue of pursuing both degrees,
CLNR 363 – New Product
the program offers students a competitive
Development 2 Semester 9
edge in the job market and rapid career
CLNR 364 – Principles of CR 2 Courses Credit Hours
advancement.
CLNR 324 – Intro. to Biostatistics 3 CLNR 690 – Research Project I 1
CLNR 451 – Scientific & Technical CLNR 691 – Research Project II 2
Semester 1 Writing 1.5 CLNR 5XX – Elective 2
Courses Credit Hours UNIV XXX – Social Science Elective 3 Total 5
CHEM 111 – General Chemistry I 4 Total 15.5
BIOL 111 – Basic Biology 4
ENGL 101 – Academic Writing 3 Semester 10
Semester 6 Courses Credit Hours
RELG 125 - Intro. to Christianity 3
Courses Credit Hours CLNR 694 – Research Project III 2
PHAR 100 – Pre-Pharmacy Sem.* 1
CLNR 328 – Intro. to Pharmacology 4 CLNR 695 – Research Project IV 2
CUC 100 – CU Connections 0.5
CLNR 442 – Interpersonal Skills 2 CLNR 5XX – Elective 2
Total 15.5
CLNR 338 – Scientific Lit. Seminar 2 Total 6
CLNR 525 – Medical Ethics 3
Semester 2 ENGL 20X – Lit. I 3 Total credit hours earned 159.5-161.5
Courses Credit Hours CLNR 517/518 – Biostatistics 4
CHEM 113 – General Chemistry II 4 Total 18 * Courses not required for BSCR degree;
BIOL 221 – Human A&P 4
however strongly recommended for pre-
ENGL 102 - Academic Writing + Lit. 3
Summer 1 pharmacy requirements.
MATH 122 – Calculus 4
Courses Credit Hours
PE 185 – Lifetime Wellness 2
CLNR 519 – Physical & Clinical **Course is not required for BSCR degree;
CUC 100– CU Connections 0.5
Assessment w/ Lab 2 however it is recommended.
Total 17.5
CLNR 561 – Healthcare Economics 2
CLNR 552 – Scientific Comm. 2
Total 6
12 2014-2015 Academic Bulletin*** All BSCR students must submit and Electives Credit Hours Course Descriptions
pass a criminal background check and drug CLNR 504 – Special Research in
screen. Students must have all necessary Clinical Research* 1-2 CLNR 101 - Introduction to Clinical Research
immunizations in order to be placed on CLNR 510 – Pharmacokinetics 2 Credit: 1 Hour
internship. Please refer to the General CLNR 528 – Pharmacogenetics 2 This course is designed to provide a broad
Information section of the Academic Bulletin CLNR 529 – Epidemiology 2 understanding of clinical research and a basic
for more specific details. CLNR 539 – Medical Genomics 2 overview of the clinical research industry.
The course provides students with a basic
CLNR 541 – Behavioral Medicine 2
understanding of key clinical research topics
^ Biology electives must be Bio-Medical CLNR 550 – Intro. to Public Health 2 allowing students a foundation to continue
electives. (Examples include, but are not CLNR 555 – Special Populations their pursuit of a degree in clinical research
limited to, Advanced Physiology, Biomedical in Clinical Research 2 and a career in the clinical research industry.
Ethics, Developmental Anatomy, Cellular CLNR 560 – Pharmacoeconomics 2
& Molecular Biology (pre-requisite for CLNR 562 – Preclinical Drug CLNR 320 – Regulatory Affairs
Microbiology & Immunology) (pre-requisite Development 2 Credit: 3 Hours
for Medical Microbiology), Cytology/Histology, CLNR 573 – Evidence-Based This introductory course emphasizes the
Bioinformatics, Genetics, Immunology, Medicine 2 terminology and basic concepts of the
pharmaceutical regulation by the Food
Advanced Cell & Molecular Biology, and CLNR 574 – Integrated Drug Safety 2
and Drug Administration, as it applies to
Biochemistry). CLNR 578 – Biopharmaceutics* 3 drugs, medical devices, and biological and
CLNR 581 – Pharmaceutical veterinary product development. The course
Compliance & QA 2 will include discussion of data submission
MS in Clinical Research Online
CLNR 593 – Leadership requirements, quality procedure regulations,
Students are required to complete the
Development 2 marketing considerations. Practical exercises
following courses in addition to 3.5 credits will be representative of tasks assigned to
CLNR 595– Bioterrorism & Mass
hours of elective courses: employees seeking entry level positions
Public Health Threats 2
CLINICAL RESEARCH
within the industry.
Core Courses Credit Hours For students pursuing the Bachelor of Applied
With approval from the course instructor and
CLNR 505 – Princ. of Clin. Research 1.5 Science (BAS) Degree only: Offered all terms
associate dean of academic affairs, PHAR
CLNR 515 – New Product
courses may serve as electives. CLNR 324 – Introduction to Biostatistics
Development 1.5
CLNR 517 – Biostatistical Inference 2 Credit: 3 Hours
*Permission of instructor required. This course, which focuses on statistical
CLNR 518 – Intro. to Biostatistical
methods in health sciences, is intended to
Modeling 2 provide the student with basic knowledge
Federally supported financial aid requires
CLNR 519/L – Physical & Clinical of descriptive statistics, graphing data,
a minimum of half-time enrollment 2 credit
Assessment with Lab 2 probability theory, normal and other common
hours per academic term (3 credit hours).
CLNR 520 – Adv. Data Management 2 distributions, sampling and estimation,
CLNR 525 – Medical Ethics 3 hypothesis testing, ANOVA and other selected
NOTE: Please refer to our website at statistical methods.
CLNR 530 – Regulatory Affairs 3
www.campbell.edu/cphs for the most
CLNR 552 – Scientific Comm. 2
up to datecurrent curriculum and tuition CLNR 326 – Principles of Clinical
CLNR 559 – Managing & Monitoring
information. Biochemistry
Clinical Trials 3
Credit: 3 Hours
CLNR 561 – Healthcare Economics 2 This course discusses the basic biochemical
CLNR 566 – Advanced Study Design principles of quantitative analysis utilized
& Analysis 3 in common clinical laboratory tests. An
CLNR 568 – Project Management 2 introduction to interpretation of abnormal
CLNR 606 – Clin. Research Seminar 2 clinical laboratory values is presented.
CLNR 690 – Research Project I 1 Quantitative aspects of nutrition are
CLNR 691 – Research Project II 2 presented, and regulatory effects of various
CLNR 694 – Research Project III 2 hormones are described.
Prerequisite: CHEM 227 & 228
CLNR 695 – Research Project IV 2
CLNR 328 – Introduction to Pharmacology
Credit: 4 Hours
The basic principles of drug action are
covered through discussion of the responses
of biological systems to drugs and chemicals.
Emphasis is place on understanding
mechanism of action through detailed
exploration of receptor-mediated events
www.campbell.edu/cphs 13(pharmacodynamics). The course considers chosen by the faculty and students. These CLNR 363 – New Product Development
the quantification of drug action as well as skills are applied in the form of written and Credit: 2 Hours
the absorption, distribution, metabolism, and oral presentations of projects developed New Product Development provides an
elimination of xenobiotics (pharmacokinetics) by researching the current biomedical and introductory overview of the process of
and how these and other factors relate to pharmaceutical literature. developing a molecule into a therapeutic
drug action. Prerequisite: CLNR 451 agent. This course provides an overview
Prerequisite: Anatomy & Physiology & CHEM of the process from discovery through
227 CLNR 336 - Scientific Literature Seminar II regulatory approval and introduction to the
Credit: 1 Hour market place. A perspective of the interaction
CLNR 330 – Regulatory Affairs I This interactive class is a continuation of required between Research & Development
Credit: 2 Hours CLNR 334, Scientific Literature Seminar I. The and marketing in order to insure product
This course provides the student with an class focuses on the continued application success in a regulated environment will be
overview of the regulatory affairs universe, of skills relating to literature searching provided. Students will be provided with the
with emphasis on requirements for initiating and critical analysis techniques, skills that background necessary to pursue a wide range
clinical trials, developing pharmaceutical were introduced in CLNR 334. These skills of additional courses leading to degrees in
products, and gaining approval for worldwide are applied in the form of two solo oral clinical research.
marketing applications. This is the first of presentations.
two required regulatory affairs courses in the Prerequisite: CLNR 334 & 451 CLNR 364 – Principles of Clinical Research
BSCR program. Credit: 2 Hours
CLNR 341 – Medical Terminology This course will provide a broad understanding
CLNR 332 – Communicating Scientific Credit: 1 Hour of clinical research including purpose,
Research This course is designed to introduce students terminology, and methodology. The course will
Credit: 3 Hours to the language of the clinical research and explore basic elements of clinical research
This course is designed to enable students medical communities. Instruction will engage including such topics as study design, data
to effectively and accurately write a variety students and provide them an opportunity to management, conduct, and the various roles
of technical documents used in the clinical learn, understand, and apply the terminology of those involved in industry.
research industry. This interactive class in context of clinical research and medical
introduces students to literature searching settings. CLNR 365– Managing & Monitoring Clinical
and critical analysis techniques. Skills in Trials I
critical analysis of the scientific literature CLNR 360 – Managing and Monitoring Credit: 2 Hours
will be developed in small group discussion Clinical Trials This introductory course has been designed
of scientific papers chosen by the faculty Credit: 3 Hours to provide both a theoretical and practical
and students. These skills are applied in This course is designed to provide both a overview of the principles of managing and
the form of written and oral presentations of theoretical and practical overview of the monitoring clinical trials. Lectures will focus
projects developed by researching the current principles of managing and monitoring clinical on the practical aspects of study set-up
scientific literature. trials. Lectures will focus on the practical activities (i.e., study planning issues, data
aspects of student set-up activities (i.e., study collection strategies, selecting investigators),
CLNR 333 – Clinical Research Ethics planning issues, data collection strategies, study conduct activities (i.e., subject
Credit: 2 Hours selecting investigators), student conduct recruitment issues and enrollment strategies,
The course will focus on biomedical ethics activities (i.e., subject recruitment issues and obtaining informed consent, monitoring both
as it relates to clinical research. However, enrollment strategies, obtaining informed patient and safety data quality and integrity
medical ethics in clinical practice may also be consent, monitoring both patient and safety and conducting site visits for study initiation,
addressed. Historical cases as well as current data quality and integrity and conducting site periodic monitoring and multiple site
events will be extensively used to highlight visits for study initiation, periodic monitoring closings), and study termination activities.
key principles of medical ethics. During the and multiple site closings), and study The course also covers responsibilities of
course, students will satisfy the requirement termination activities. The course also covers sponsors, clinical monitors, clinical research
of human subjects training required for responsibilities of sponsors, clinical monitors, organizations, investigators and institutional
clinical investigators by the National Institutes clinical research organizations, investigators, review boards. In-class activities will allow
of Health. research coordinators and institutional students to gain a greater appreciation
For students pursuing the Bachelor of Applied review boards. In-class activities will allow of operational issues associated with
Science (BAS) Degree only: Offered all terms students to gain a greater appreciation various clinical research-related regulatory
of operational issues associated with documents by working with case studies
CLNR 334 – Scientific Literature Seminar I various clinical research-related regulatory related to the content studied. Lectures are
Credit: 1 Hour documents by working with case studies based on U.S. regulations and guidelines, as
This course is the first in a two-part series. The related to the content studied. Lectures are well as international good clinical practices
skills developed in this class will be further based on U.S. regulations and guidelines, as and significant clinical research-related
refined in CLNR 336, Scientific Literature well as international good clinical practices documents.
Seminar II. This interactive class introduces and significant clinical research-related Prerequisites: CLNR 363 & 364
students to literature searching and critical documents.
analysis techniques. Skills in critical analysis For students pursuing the Bachelor of Applied
of the scientific literature will be developed Science (BAS) Degree only: Offered all terms.
in small group discussion of scientific papers
14 2014-2015 Academic BulletinCLNR 379 & 379L – Physical & Clinical resolution, interviewing, and presentation CLNR 504 – Special Research in Clinical
Assessment with Lab skills. The course will provide a forum for Research
Credit: 2 Hours group discussions and writing exercises. Credit: 1-2 Hours
This course is designed to introduce students This course will introduce the graduate
to the basic principles of medical terminology, CLNR 450 – Data Management student to the scientific inquiry process
history taking, the basic techniques of physical Credit: 3 Hours used in clinical and scientific research. This
examination assessment, and diagnostic test This introductory course covers topics such as involves application of the scientific process
data. the role of data management in clinical trials including but not limited to: literature
Prerequisite: Anatomy & Physiology and the duties of the evaluation, literature search, design of project,
Clinical Data Coordinator. Topics include development of written and verbal skills, data
CLNR 416 – Senior Seminar organization, collection, review, and tracking acquisition and analysis, use of web-based
Credit: 1 Hour of data. Coding of data and standardized systems and data and project management.
This course is designed to prepare the student terminology are also considered. The course
for real world practices. The student will learn will also include instruction utilizing modern CLNR 505 – Principles of Clinical Research
and review research, presentation and public electronic data collection methods. Credit: 1.5 Hours
speaking techniques and utilize these to Prerequisites: CLNR 363 & 364 This course will provide a broad understanding
prepare a research paper and presentation. of clinical research - definition, methodology,
This course culminates in a presentation day CLNR 451 – Scientific & Technical Writing conduct and applications. The course will
where each student will present their research Credit: 1.5 Hours explore the basic elements of clinical research
information and internship experience to the Scientific and Technical Writing is a required including the hierarchy of clinical trial design,
Department of Clinical Research and honored course for Clinical Research majors designed clinical trial conduct, and safety surveillance.
guests. to enable students to effectively and accurately Application of clinical trial knowledge to
Co-requisite: CLNR 420 write a variety of technical documents used in specific medical practice issues will also be
pharmaceutical-related industries. explored.
CLNR 420 – Senior Internship
Credit: 14 Hours CLNR 465 – Managing & Monitoring Clinical CLNR 510 – Pharmacokinetics
This course is an experiential learning Trials II Credit: 2 Hours
CLINICAL RESEARCH
system, which allows the BSCR students an Credit: 2 Hours Pharmacokinetics involves the rates
opportunity to gain hands on experience in This course will continue to build upon of liberation, absorption, distribution,
the clinical research profession. Students concepts introduced and developed in metabolism, and excretion of drugs and
and participating institutions are matched to CLNR 365, Managing and Monitoring chemicals in the body. A basic course in
provide a comprehensive work experience. Clinical Trials I. Additional material will be pharmacokinetics examines these principles
The internship is designed for a BSCR added as appropriate, and students will from the mechanistic, mathematical,
candidate to develop strong clinical research achieve a greater depth of knowledge and and graphical perspectives, and provides
skills while improving his/her knowledge in understanding about topics covered in the a scientific approach to rational drug
the field of clinical research. first course. selection and therapy. The principles
Prerequisite: Completion of all BSCR courses Prerequisites: CLNR 363, 364, 365 & 450 governing liberation, absorption, distribution,
and at least a 2.0 major and cumulative GPA metabolism, and excretion will be presented.
Co-requisite: CLNR 416 CLNR 468: Clinical Project Management The rates or kinetics of these processes,
Credit: 2 Hours and the mathematical methods associated
This course introduces concepts of clinical with pharmacokinetics, will be examined.
CLNR 440 – Regulatory Affairs II project management that should be applied Application of theoretical principles will
Credit: 2 Hours while managing projects in the clinical be extended to examine drug product
This course builds upon concepts developed research industry. The full life cycle of a equivalency, dosage regimen design, and
in Regulatory Affairs I and provides more project will be studied including project dosage adjustment in renal and/or liver
detailed and broader coverage of the initiation, planning, execution, control and failure.
terminology and concepts that address the closeout. Students will be exposed to the This course is co-listed as PHAR 410
regulation of the pharmaceutical industry by principles of project management as it Prerequisites: PHAR 304 & 314
the Food and Drug Administration, with an applies specifically to clinical research. Permission of instructor required.
emphasis on the drug, biologic and veterinary Managing an individual clinical trial will
product development and approval process. be covered; the broader perspective of CLNR 515 – New Product Development
Prerequisites: CLNR 363, 364 & 330 managing new drug development projects in Credit: 1.5 Hours
the pharmaceutical industry will be a major New Product Development provides an
CLNR 442 – Interpersonal Skills focus. The project manager integrates basic introductory overview of the process of
Credit: 2 Hours research, pharmacology, toxicology, chemical developing a molecule into a therapeutic
In this course, students will learn about the development, analytical development, agent, as well as an overview of the process
various factors involved in developing good pharmacokinetics, metabolism, clinical from discovery through regulatory approval
interpersonal speaking and writing skills research, and marketing aspects for delivering and introduction to the market place. This
including: self-awareness, understanding a new product to the marketplace. course will provide a perspective of the
individual differences, goal setting, listening For students pursuing the Bachelor of Applied interaction required between Research &
and providing feedback, teamwork, Science (BAS) Degree only: Offered all terms Development and marketing in order to ensure
leadership development and motivating product success in a regulated environment.
others, delegation, negotiation, conflict
www.campbell.edu/cphs 15It is designed to provide students with the focus on medical ethics as it relates to clinical CLNR 541 – Behavioral Medicine
background necessary to pursue a wide range research. However, medical ethics in clinical Credit: 2 Hours
of additional courses leading to degrees in practice may also be addressed. Historical This elective course will examine the
clinical research. cases as well as current events will be pathophysiology, diagnosis, pharmacology,
extensively used to highlight key principles of treatment guidelines, and current literature
CLNR 517 – Biostatistical Inference medical ethics. During the course, students for a variety of psychiatric disorders. The
Credit: 2 Hours will satisfy the requirement of human subjects course will cover current controversies
This course is intended to provide students training required for clinical investigators by surrounding clinical research and evidence-
with the basic knowledge of estimation, the National Institutes of Health. based decisions in psychiatry. Topics will
hypothesis testing, sample size and power include the following: schizophrenia, bipolar
analysis, and other selected statistical CLNR 528 – Pharmacogenetics disorder, depression, and other psychiatric
methods including two sample tests, Credit: 2 Hours disorders.
contingency table inference and odds Population genetics, disease state prevalence,
rations. Applications of the methodology and and population variances in response to drug CLNR 550 – Introduction to Public Health
interpretation of results is the primary focus therapy are covered in this course. The impact Credit: 2 Hours
of the course. of pharmacogenetics on the future of clinical The course provides a comprehensive
Prerequisite: CLNR 324, MATH 160 or trials will be considered. examination of the basic and critical issues
approved general Statistics course Prerequisites: CLNR 505, 515 & 518 in public health for pharmacists. The course
This course is co-listed as PHAR 594 and content includes a basic knowledge base of
CLNR 518 – Introduction to Biostatistical PHSC 564. public health issues, an exploration of the
Modeling various roles that pharmacy can provide in
Credit: 2 Hours CLNR 529 – Epidemiology offering public health services, and examples
This course is intended to provide students Credit: 2 Hours of unique applications to pharmacy practice.
with an introduction to, and basic knowledge This course presents an overview of Issues in public health care are examined
of, statistical modeling including one-way epidemiology and how the field augments both from the pharmacy perspective and the
analysis of variance (ANOVA) and simple clinical research. The course emphasizes traditional public health viewpoint.
and multiple linear and logistic regression. an introduction to the application of
Applications of the methodology and epidemiological methods. The primary goal CLNR 552 – Scientific Communications
interpretation of results is the primary focus of the course is to orient students to the field Credit: 2 Hours
of the course. of epidemiology and foster an appreciation for This course briefly reviews fundamental
Prerequisite: CLNR 517 the methods used to do observational studies communication skills, and then teaches
Co-req: CLNR 520 in “real world” settings. scientific communication in both written and
Prerequisites: CLNR 505 & 518 verbal forms. Regulatory documentation,
CLNR 519 & 519L – Physical & Clinical abstracts, posters, manuscripts, and
Assessment with Lab CLNR 530 – Regulatory Affairs professional reports are covered. Oral
Credit: 2 Hours Credit: 3 Hours presentation skills are also covered.
This course is designed to introduce the This course provides the student with an Interpersonal skills are developed in team
student to medical terminology, medical overview of the regulatory affairs universe, project work.
history taking, basic physical examination with emphasis on requirements for initiating
techniques, and diagnostic tests commonly clinical trials, developing pharmaceutical CLNR 555 – Special Populations in Clinical
used in clinical research protocols. products, and gaining approval for marketing Research
Prerequisite: Anatomy & Physiology applications. Emphasis will be placed on Credit: 2 Hours
the practical application of regulations This course will cover topics and issues
CLNR 520 – Advanced Data Management in the commercialization of healthcare associated with conducting clinical research
Credit: 2 Hours products. This will include data submission in special populations and vulnerable
This advanced course covers in detail topics requirements, quality procedure regulations, populations. The populations reviewed will
such as the role of data management in marketing considerations, and post-approval include pediatrics/adolescent, geriatrics,
clinical trials and the duties of the Clinical requirements including safety reporting. obstetrics/women issues, and ethnic
Data Coordinator. Topics include organization, Prerequisites: CLNR 505 & 515 minorities. Current regulatory mandates
collection, review, and tracking of data. Coding and guidance will be covered and issues
of adverse drug experiences, drugs and CLNR 539 – Medical Genomics unique to each special population will be
disease states, and standardized terminology Credit: 2 Hours discussed such as measurement challenges,
are also considered. This course starts by teaching basic genomics recruitment, ethics, and IRB issues.
Prerequisites: CLNR 505 & 515 and molecular biology. Attention then focuses
Co-req: CLNR 518 on the benefits of this knowledge in biomedical CLNR 559 – Advanced Managing &
research and medicine. Examples of topics Monitoring of Clinical Trials
CLNR 525 – Medical Ethics discussed include pharmacogenomics and Credit: 3 Hours
Credit: 2 Hours toxicology, an awareness of the ethical, legal, CLNR 559, “Managing and Monitoring Clinical
This course will use a combination of lectures, and social implications of genomic research, Trials”, provides an in-depth introduction to
interactive discussion, case presentations, and the potential future implementation of the principles of managing and monitoring
and student presentations to explore the field Precision Medicine and Information-based clinical trials. The varied environments in
of medical ethics. The course will primarily Medicine. which clinical research is conducted are
described and the roles of the different
16 2014-2015 Academic Bulletinpersonnel involved in a clinical trial will be is placed on promising approaches expected be exposed to the process of evaluating the
detailed. Students will be introduced to the to lead to novel therapies and drug delivery validity and usefulness of this information in
elements of clinical trial protocols and data systems within the next decade. A focus on order to incorporate it into clinical practice.
collection strategies. The course will provide illustrating future therapeutic targets and Prerequisites: CLNR 505, 515 & 518
an overview of regulations relevant to clinical drug delivery systems is included.
trials including responsibilities of sponsors, Prerequisites: CLNR 505 & 515 CLNR 574 – Integrated Drug Safety
investigators, institutional review boards, and Credit: 2 Hours
contract research organizations. In addition, CLNR 566 – Advanced Study Design & This course provides students with a
the course will cover selection of investigators, Analysis comprehensive introduction to the many
conduct of investigator meetings, procedure Credit: 3 Hours facets of contemporary pharmaceutical and
for site monitoring visits (study initiation, This course presents a selection of study biologic drug safety. A lifecycle development
periodic monitoring, close-out and study designs and statistical analyses that are most approach is taken, whereby discussions of
termination), patient enrollment issues, safety relevant to clinical research. The course will drug safety considerations during in silico
monitoring, case report form review, and data also present research question development, simulation modeling, drug discovery, in vivo
management. Students will become familiar endpoints, database utilization and sample and in vitro nonclinical research, preapproval
with Good Clinical Practices (GCPs), Standard size calculation. The course emphasizes clinical research, and post marketing
Operating Procedures (SOPs), the quality the application of these topics beyond just surveillance are fully integrated.
assurance process (QA), and FDA audits. understanding the concepts. The role of
Prerequisites: CLNR 505 & 515 clinical research in providing the evidence for CLNR 578 – Biopharmaceutics
Evidence-based Medicine is considered. The Credit: 3 Hours
CLNR 560 – Pharmacoeconomics primary goal of the course is to present the This course presents the biological and
Credit: 2 Hours concepts that are crucial to prepare students physiochemical factors of the body, drugs and
Students will become aware of the various for CLNR 690/695 Research Project I/II, dosage forms that influence drug availability,
tools, methods, and strategies to evaluate and develop the knowledge for the central disposition and pharmacological and
the economic contribution of specific drug importance of statistical thinking in clinical toxicological responses.
therapies at a variety of levels. Rising health research (from initial conceptualization of This course is co-listed as PHAR 314.
care costs will force decisions to be made the study, through design, statistical analysis Permission of instructor required
CLINICAL RESEARCH
regarding the overall cost implications as plans, statistical analysis, and interpretation),
well as the effectiveness of the technology. rather than to become experts in computation. CLNR 581 – Pharmaceutical Compliance &
The application of such pharmacoeconomic Prerequisite: CLNR 505, 515 & 518 Quality Assurance
analyses to clinical practice and Credit: 2 Hours
pharmaceutical care will be instrumental CLNR 568 – Project Management This course is designed to provide an overview
to pharmacy’s success in our future health Credit: 2 Hours of the process of compliance and quality
care delivery. This course will be presented This course will introduce the generic assurance activities within the Pharmaceutical
utilizing a parallel learning model whereby concepts of professional project management Industry. Emphasis will be placed on auditing
students will be asked to give and receive that should be applied while managing fundamentals, audit processes and tools,
information about pharmacoeconomics. projects in several industries. The full life quality program management as well as
This course is co-listed as PHAR 561. cycle of a project will be studied including FDA compliance activities. Students may be
project initiation, planning, execution, exposed to a variety of industry experts during
CLNR 561 – Healthcare Economics control and closeout. The project manager’s the course. Emphasis will also be placed on
Credit: 2 Hours role in developing and maintaining the Good Manufacturing Practices (GMP), Good
This course will give participants an in-depth timeline, budget, and quality of a project Laboratory Practices (GLP) and Good Clinical
international perspective on healthcare will be defined. Students will be exposed to Practices (GCP). Students will gain a practical
economics. This perspective will be delivered the principles of project management as knowledge of Quality as a scientific discipline.
by starting at the macro-economic, global it applies specifically to clinical research. Prerequisites: CLNR 505, 515, 530 & 559
level and then narrowing the focus of study to While managing an individual clinical trial
numerous national healthcare systems and will be covered, the broader perspective of CLNR 593 – Leadership Development
landmark case studies. All case studies will managing new drug development projects in Credit: 2 Hours
be aimed at measuring the economic impact the pharmaceutical industry will be a major This course is intended for students
of specific healthcare crises. Each case will focus. In the latter, the project manager who are contemplating a management/
be preceded by the description of cultural integrates basic research, pharmacology, leadership career track. The lectures present
values that impact healthcare delivery and toxicology, chemical development, analytical fundamental skills of organizational behavior
government response in the event of a development, pharmacokinetics, metabolism, and leadership that are essential to effectively
healthcare crisis. clinical research, and marketing aspects for managing and leading both direct reports
delivering a new product to the marketplace. and project teams. The course involves
CLNR 562 – Preclinical Drug Development Prerequisite: CLNR 505 & 559 lectures supported by video presentations,
Credit: 2 Hours group discussion, and role play. Participant
This course provides students with an overview CLNR 573 – Evidence-Based Medicine materials can be retained by the student for
of the process of classical and modern drug Credit: 2 Hours future use/reference in the workplace. The
development. The course will also provide a This course will trace formulation of relevant course contains both theoretical content, as
perspective of the interaction of research, questions from clinical cases through the well as an examination of processes involved
development and marketing activities in a methodology required to search the clinical in human behaviors in the healthcare
regulated environment. Particular emphasis literature for critical information. Students will organizational setting. Due to the heavy
www.campbell.edu/cphs 17emphasis on process, participation and and research hypotheses. In later research CLNR 695– Research Project IV
group-intensive instructional approaches are project courses, the student will develop a full Credit: 2 Hours
used in the course; there are three primary Study Protocol describing the methodology This course is the fourth part of the four-part
student goals for the course: that will be employed in the study, and then Research Project course, which comprises
Demonstrate mastery of the content as ultimately conduct the study and present CLNR 690, 691, 694, and 695. The student
specified in the course objectives; apply the study results. will utilize prior didactic experience in the
theories to case studies and Develop an Prerequisites: All core courses; 3.0 GPA Clinical Research Program to propose,
understanding of your own managerial style. Co-requisite: CLNR 525 & 606 design, and conduct the research project.
The research project must involve patient-
CLNR 595 – Bioterrorism & Mass Public CLNR 691- Research Project II oriented research, including: epidemiologic
Health Threats Credit: 2 Hours and behavioral studies, health outcomes
Credit: 2 Hours This course is the second part of the four-part research, and /or health services research.
This course provides an overview of current Research Project course, which comprises The project will be conducted under the
issues related to bioterrorism and mass CLNR 690, 691, 694, and 695. The student supervision of the Course Director. Students
threats to public health. Details of specific will utilize prior didactic experience in the will have an internal faculty advisor who is a
risks of threat entities and their treatment Clinical Research Program to propose, full-time faculty member in the Department
will be taught. An emphasis is placed on design, and conduct the research project. of Clinical Research, as well as a Statistician
response planning and preparation. The research project must involve patient- faculty member of the Department of Clinical
Co-listed as PHAR 595 oriented research, including: epidemiologic Research assigned to advise them throughout
and behavioral studies, health outcomes the project. In this course, students will
CLNR 606 – Clinical Research Seminar research, and /or health services research. validate study data, conduct their statistical
Credit: 2 Hours The project will be conducted under the analysis, present study results, and write/
This seminar is intended to assist the student supervision of the Course Director. Students submit a final Study Report.
in developing critical thinking skills in clinical will have an internal faculty advisor who is a
research design and analyses of data. The full-time faculty member in the Department Campbell University College of Pharmacy &
course will reinforce learning of experimental of Clinical Research, as well as a Statistician Health Sciences reserves the right to make
methods in clinical research by analyzing faculty member of the Department of Clinical changes in the curriculum or policy of any
manuscripts in the published literature. Research assigned to advise them throughout program as it deems necessary.
Students will learn criteria for quality that will the project. In this course, students will
allow them to distinguish those studies with further develop a written Research Proposal,
the strongest validity. They will apply statistical and once approved, will develop this into a full
methodology and knowledge of study design Research Protocol. In later research project
that they acquired in previous courses. courses, the student will ultimately conduct
Students will develop an understanding of the study and present study results.
the limitations of data and study design. Prerequisite: CLNR 690
The skills developed in this course will assist
those students who will be writing their own CLNR 694 - Research Project III
manuscripts. The course will also prepare Credit: 2 Hours
students to report on their research project. This course is the third part of the four-part
Prerequisites: CLNR 505, 515, 518 & 566 Research Project course, which comprises
CLNR 690, 691, 694, and 695. The student
CLNR 690 - Research Project I will utilize prior didactic experience in the
Credit: 1 Hour Clinical Research Program to propose,
This course is the first part of the four-part design, and conduct the research project.
Research Project course, which comprises The research project must involve patient-
CLNR 690, 691, 694, and 695. The student oriented research, including: epidemiologic
will utilize prior didactic experience in the and behavioral studies, health outcomes
Clinical Research Program to propose, research, and /or health services research.
design, and conduct the research project. The project will be conducted under the
The research project must involve patient- supervision of the Course Director. Students
oriented research, including: epidemiologic will have an internal faculty advisor who is a
and behavioral studies, health outcomes full-time faculty member in the Department
research, and /or health services research. of Clinical Research, as well as a Statistician
The project will be conducted under the faculty member of the Department of Clinical
supervision of the Course Director. Students Research assigned to advise them throughout
will have an internal faculty advisor who is a the project. In this course, students will
full-time faculty member in the Department finalize their Research Protocol, obtain IRB
of Clinical Research, as well as a Statistician approval /exemption (as appropriate) and
faculty member of the Department of Clinical develop a Data Analysis Plan for their project.
Research assigned to advise them throughout In the last research project course, the
the project. In this course, students will student will analyze their data and present
develop and submit a written Research study results.
Proposal describing their research question(s) Prerequisite: CLNR 691
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