UNCW UNIVERSITY COLLEGE
2009-2010 CATALOGUE
B.S. Clinical Research (CLR)
College: School of Nursing
DEGREE REQUIREMENTS
Course requirements for all UNCW degrees include: (1) Basic Studies, (2) specific major requirements, and (3) sufficient
elective hours for a combined total of a minimum of 125 hours.
(1) BASIC STUDIES (45 semester hours)
See Basic Studies sheet and/or information on the WEB at http://www.uncw.edu/uc/basicstudies.htm
(2) MAJOR REQUIREMENTS – CLR (Minimum 99 hours)
Check when complete:
Specific Basic Studies and Collateral Course Requirements:
_____+*BIO 201
Principles of Biology: Cells (4)
_____+*BIO 240-241
Human Anatomy and Physiology I and II (4-4) Prerequisite: BIO 201 and CHM 101
_____*BIO 246
Microbiology of Human Diseases (4) Prerequisite or Co-requisite: BIO 240
_____+MAT 111
College Algebra (3) Prerequisite: Satisfactory performance on the UNCW MAT Placement Test
_____+PAR 215
Bioethics (3)
_____+STT 210
Introduction to Statistics w/ Applications in the Health Sciences (3) Prerequisite: MAT 111
_____+*CHM 101-102
General Chemistry (4-4)
_____ *CHM 211
Organic Chemistry (4) Prerequisite: CHM 102
_____ CSC 110
Fluency in Information Technology (3)
_____+PSY 105
General Psychology (3)
_____+PSY 223
Lifespan Human Development (3) Prerequisite: PSY 105
_____+SOC 105
Introduction to Sociology (3)
_____ SOC 345 or PSY 366 Sociology of the Family (3) Prerequisite: SOC 105 or Psychology of Marriage and Family (3) Prerequisite: PSY 105
Core Requirements:
_____*NSG 250
Introduction to Health Assessment (2) NSGL 250 Lab (1) Prerequisite: Admission to the School of NSG
_____ NSG 325
Introduction to Pharmacotherapeutics (3) Recommended Prerequisites: BIO 240, 241, 246
_____ CLR 301
Basics of Clinical Research (3) (Meets Computer Competency Requirement)
_____ CLR 305
Clinical Research Seminar (2) (Meets Oral Communication Competency Requirement)
_____ CLR 310
Scientific Writing (3)
_____ CLR 320
Scientific Literature Seminar (3)
_____ CLR 330
Fundamentals of Product Development (3)
_____ CLR 410
Advanced Scientific Writing (3)
_____ CLR 420
Regulatory Affairs (2)
_____ CLR 430
Managing and Monitoring Clinical Trials (2)
_____ CLR 440
Pharmacoeconomics (3)
_____ *CLRL 450
Data Management (3) Lab (1)
_____ CLR 498
Senior Internship (12)
_____ CLR 460
Senior Seminar (2)
_____ MKT 340
Principles of Marketing (3) Prerequisite: Junior standing
Requirements for Admission to the Bachelor of Science in Clinical Research Program:
•
Admission to the University of North Carolina Wilmington
•
Completion of UNCW Basic Studies and required CLR program prerequisite and collateral courses: BIO 201, 240, 241, 246;
CHM 101, 102, CSC 110; MAT 111; PSY 105, 223; SOC 105; STT 210
•
Grade of “C” (2.0) or better in required science courses
•
Completed application to Clinical Research Program with application fee
•
Recommendation of Student Affairs Committee in School of Nursing
•
Approval of the Clinical Research Faculty and the dean
•
Negative drug screen and negative criminal background check
Clinical Lab/Internship Requirements include:
•
Current immunization record (including TB or chest x-ray and Hepatitis B)
•
Verification of health insurance
•
CPR certification
•
Negative drug screen
•
Professional liability insurance
•
Negative criminal background check
Note: Program requirements must be adjusted to accommodate new competencies and regulatory guidelines. Students are advised to check
with the academic advisor(s) or the associate dean for academic affairs in the School of Nursing to keep abreast of programmatic changes.
A minimum of “C” (2.0) is required in each required Clinical Research Major course in order to progress in the major. A
cumulative GPA of 2.0 or better is required for graduation.
*These courses require a lab
+May also be used to satisfy Basic Studies requirements. NOTE: Completion of these courses will satisfy university Basic Studies
requirements in the social and behavioral sciences, philosophy and religion, and the natural and mathematical sciences.
(3) ELECTIVES _____ Elective hours to equal a minimum of 125 hours
Requirements to declare Pre-CLR: Completion of 24 credit hours.
Requirements to declare CLR: See listing above and in the UNCW undergraduate catalogue.
Information: NSG WEB at http://www.uncw.edu/son and http://www.uncw.edu/catalogue/sonurs.htm; E-mail: son@uncw.edu
05/29/09
CLINICAL RESEARCH DEGREE REQUIRED COURSES
Note: Admission to the Clinical Research Degree Program is required for enrollment in the core courses. Requirements
include the following:
61 hours Concentration in Clinical Research
64 hours Basic Studies and Prerequisites/Collateral Courses
125 total Semester Credit Hours
Basic Studies, Prerequisite, and Collateral Courses:
BIO 201.
Principles of Biology: Cells (4)
BIO 240-241.
Human Anatomy and Physiology (4-4)
BIO 246.
Microbiology of Human Diseases (4) Prerequisite or corequisite: BIO 240
CHM 101-102.
General Chemistry (4-4)
CHM 211.
Organic Chemistry (3) Lab. (1) Prerequisite: CHM 102
CSC 110.
Fluency in Information Technology (3)
ENG 101-201.
College Writing and Reading I and II (3-3) Prerequisite: Evidence of competence on placement
or ENG 103.
College Writing and Reading (Advanced) (3) Prerequisite: Special competence on placement
MAT 111.
College Algebra (3) Prerequisite: Satisfactory performance on UNCW placement test or MAT 105
MKT 340.
Principles of Marketing (3) Prerequisite: Junior standing
NSG 250.
Introduction to Health Assessment (2) Lab (1) Prerequisite: Admission to the School of Nursing
or special permission
NSG 325.
Introduction to Pharmacotherapeutics (3) Prerequisites: BIO 240, 241, 246
PAR 215.
Bioethics (3)
PED 101.
Physical Activity and Wellness (2)
PSY 105.
General Psychology (3)
PSY 223.
Life Span Human Development (3) Prerequisite: PSY 105
PSY 366.
Psychology of Marriage and Family (3) Prerequisite: Three hours of psychology
or SOC 345.
Sociology of the Family (3) Prerequisite: SOC 105
SOC 105.
Introduction to Sociology (3)
STT 210.
Introduction to Statistics with Applications in the Health Sciences (3) Prerequisite: MAT 111
Clinical Research Courses:
CLR 301. Basics of Clinical Research (3) Definition and purpose of clinical research. Description of various research
environments, research approaches, and selected computer applications in research. Evolutionary trends in the medical,
pharmaceutical, biologic, and device industry. Description of how clinical research is utilized to evaluate new products
(drugs, devices, diagnostics, biologicals) and protocols. Confidentiality and privacy issues. Overview of the impact of politics
and advocacy on research priorities.
CLR 305. Clinical Research Seminar (2) In-depth investigation and comparison of clinical research methodologies,
protocols, and dissemination of a chosen topic presented by each student.
CLR 310. Scientific Writing (3) Principles and practice with emphasis on critical thinking, brainstorming, outlining,
researching, and writing processes. Writing of such documents as standard operating procedures (SOPs), proposals, short
reports, and letters.
CLR 320. Scientific Literature Seminar (3) Dissemination of scientific knowledge in various literary forms with critical
analysis of how knowledge is relayed. Discussion, brief written assignments, and a research paper.
CLR 330. Fundamentals of Product Development (3) Broad view of product development. Process of development from
early research, discovery, and formulation to include safety and efficacy requirements.
CLR 410. Advanced Scientific Writing (3) Focus on the writing of documents required in biopharmaceutical and other
organizations such as informed consent, protocols, and manuscripts. Critical thinking regarding documents and application to
how organizations function. Discussion, three essays with expansion of one into final project of publishable quality.
CLR 420. Regulatory Affairs (2) In-depth coverage of the requirements for worldwide marketing applications.
Examination of the regulatory review process and regulatory agency interactions. Emphasis on late phase of clinical
investigations and marketing considerations, including safety reporting.
CLR 430. Managing and Monitoring Clinical Trials (2) Theoretical and practical overview of the principles and
practices guiding the clinical trial methodology to include role responsibilities, protocol development and implementation
with data collection strategies, monitoring, analysis, and reporting.
CLR 440. Pharmacoeconomics (3) Methods of cost/benefit analysis of new product development via case study format.
Exposure to research outcomes and issues in quality of life.
CLR 450. Data Management (3) Role and responsibilities of data management in clinical research from perspective of
clinical data coordinator. Topics include organization, collection, review, and tracking of data.
CLRL 450. Data Management Lab (1) Three hours of lab experience each week.
CLR 460. Senior Seminar (2) An overview of the students’ clinical research experience including a synopsis of the
individual’s role and responsibilities. A forum in which findings will be presented to peers and faculty.
CLR 498. Senior Internship (12) A practical experience at one or more clinical research site. Students and participating
organizations are matched to provide a comprehensive clinical research experience.
05/29/09