UNCW UNIVERSITY COLLEGE 2006­2007 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 204 Principles of Biology: Cells (4) _____+*BIO 240­241 Human Anatomy and Physiology I and II (4­4) Prerequisite: BIO 204 _____*BIO 246 Microbiology of Human Diseases (4) Prerequisite or Co­requisite: 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 101­102 General Chemistry (4­4) _____ *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 _____ NSG 325 _____ CLR 301 _____ CLR 305 _____ CLR 310 _____ CLR 320 _____ CLR 330 _____ CLR 410 _____ CLR 420 _____ CLR 430 _____ CLR 440 _____ *CLR 450 _____ CLR 498 _____ CLR 460 _____ MKT 340 Introduction to Health Assessment (2) NSGL 250 Lab (1) Prerequisite: Admission to the School of NSG Introduction to Pharmacotherapeutics (3) Recommended Prerequisites: BIO 240, 241, 246 Basics of Clinical Research (3) (Meets Computer Competency Requirement) Clinical Research Seminar (2) (Meets Oral Communication Competency Requirement) Scientific Writing (3) Scientific Literature Seminar (3) Fundamentals of Product Development (3) Advanced Scientific Writing (3) Regulatory Affairs (2) Managing and Monitoring Clinical Trials (2) Pharmacoeconomics (3) Data Management (3) Lab (1) Senior Internship (12) Senior Seminar (2) 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 204, 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 Clinical Lab/Internship Requirements include:
· Current immunization record (including TB and Hepatitis B)
· Verification of health insurance
· CPR certification
· Negative drug screen
· Professional liability insurance
· 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 Pre­CLR: Completion of 24 credit hours. Requirements to declare CLR: See listing above and on pp. 217­218 and p. 186 in the 2006­2007 UNCW undergraduate catalogue. For further information see the NSG WEB sites: http://www.uncw.edu/son and http://www.uncw.edu/catalogue/sonurs.htm; also E­mail: son@uncw.edu 09/25/06
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 Core Curriculum and Collateral Courses 64 hours Basic Studies and Prerequisites 125 total Semester Credit Hours Basic Studies, Prerequisite, and Collateral Courses: BIO 204. Principles of Biology: Cells (4) BIO 240­241. Human Anatomy and Physiology (4­4) BIO 246. Microbiology of Human Diseases (4) Prerequisite or Co­requisite: BIO 240 CHM 101­102. General Chemistry (4­4) CHM 211. Organic Chemistry (3) Lab. (1) Prerequisite: CHM 102 CSC 110. Fluency in Information Technology (3) ENG 101­201. College Writing and Reading I and II (3­3) Prerequisite: Evidence of competence on a Placement test or ENG 103. College Writing and Reading (Advanced) (3) Prerequisite: Special competence on a Placement test MAT 111. College Algebra (3) Prerequisite: Satisfactory performance on UNCW Placement test 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 NSG 325. Introduction to Pharmacotherapeutics (3) Prerequisites: BIO 240, 241, 246 PAR 215. Bioethics (3) PED 101. Foundations of Physical Activity (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 PSY 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) In­depth 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 companies, contract research 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) In­depth 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. 09/25/06