Clinical Research Department of Clinical Research

 
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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       9
3. 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 Bulletin
Policies & 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      11
internship. 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 Bulletin
CLNR 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        15
It 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 Bulletin
personnel 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       17
emphasis 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

18   2014-2015 Academic Bulletin
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