Catalog 73 - National University

Course DescriptionsMNS 601: Statistics for BusinessAn examination of the increasing complexity ofbusiness problem-solving confronting today’s managers,this course covers the role statistics and forecastingplay in the business decision-makingprocess, as well as the principles and steps involvedin planning and conducting business research.Within the context of this course, students proposeto study a situation that exists within an organizationalsetting and identify a faculty research advisorwith knowledge in the focus area.MRA – Clinical Regulatory AffairsMRA 600: Introduction to Regulatory AffairsThis course is designed to present an introduction tothe regulations and documents necessary for FDAapproval of a new medical device or pharmaceuticalproduct. The student will be introduced to federalregulations (CFR), human subject regulations, clinicaltrials, and evidence based documents, clinicalprotocols, data management, clinical trial data,investigational review board, and submissions ofdrug and device approval documents. An introductionto clinical and manufacturing process and standardoperating procedure documentation will alsobe included.MRA 601: Clinical DocumentationThis course will focus on the laws and regulations,documentations, and process imposed by theFederal government, especially the Food and DrugAdministration, related to pharmaceutical and medicaldevice approval and the clinical trials associatedwith the approval process. Emphasis is placed ondesigning and implementing appropriate clinicaltrial protocol documents as well as all forms associatedwith the clinical trials used for evidence baseddocumentation of the trial(s). Statistical justificationwill also be introduced for use as to methodologyand analysis of the trial.MRA 602: Human Subjects in Clinical TrialsThis course is designed to give the student the fundamentalknowledge in the protection of humansubjects in a clinical trial. The course will emphasizefederal, state, and local regulations in protecting thehealth and welfare of human subjects in a clinicaltrial. Proper documentation, HIPAA regulations,IRBs, international codes of conduct, Declaration ofHelsinki, Informed Consent, adverse events CFRs,and all other pertinent documents and codes will becovered.MRA 603: Medical Device and PharmaceuticalRegulationsThis course will focus on the laws and regulations,documentations, and process imposed by theFederal government, especially the Food and DrugAdministration, related to pharmaceutical and medicaldevice approval. The course will provide studentswith detailed knowledge and practical applicationas it applies to appropriate documentationand process of approval for pharmaceutical andmedical devices. The students will understand thenomenclature of the regulatory agencies; have athorough knowledge of the code of FederalRegulations as it applies to medical devices andpharmaceutical products.MRA 604: Coordinating and Monitoring ClinicalResearchThis course is designed to give the student comprehensiveknowledge in coordinating and monitoringclinical trials and clinical trials research. Emphasis isplaced on understanding regulations, good clinicalpractice, an overview of research, standard operatingprocedure, data documentation, preparing and404 working with subjects, monitoring clinical trials, andstudy closure.MRA 605: Analytical Methods for RegulatoryAffairsThis course will give the student the fundamentalknowledge of statistical concepts and analyticalmethods as applied to biomedical science and clinicaltrials. It will emphasize basic concepts ofmethodology and experimental design, quantitativeanalysis of data, and statistical significance. A casestudy approach will be used to cover the basicdesigns of clinical trials with emphasis on appropriatemethodologies, endpoint variables, controlgroups, blinded studies, eligibility criteria, andplacebo control. The course will cover statisticalanalysis including probabilities and variables.Students will be required to design and implement afull protocol for a fictitious drug or medical deviceelucidating the data for approval.MRA 606: FDA Regulations and SubmissionsThis course will give the student the fundamentalknowledge of FDA regulations as they apply tomedical devices and pharmaceutical products andthe documentation needed for such approval. Thecode of Federal Regulations will be utilized withemphasis on CFR 21, FDA compliance, ICH guidelinesfor international harmonization and GoodClinical Practice (GCP), investigator study files, FDAaudits, and Adverse Event reporting.MRA 610A: Research Capstone Project inRegulatory AffairsA two-month course that meets on a once a weekbasis, this course is designed to have the studentdevelop and implement a research document thatintegrates all facets of a clinical trial including regulations,documentation, clinical evidence, data management,statistical analysis of the data and otherprinciples taught throughout the entire program.Grading is by S or U only. Course is eligible for an InProgress (IP) grade.MRA 610B: Regulatory Affairs InternshipThis course is designed to give the student a “handson” real world experience working in a clinical trialenvironment. The student will acquire fundamentalknowledge in evidence based clinical data, statisticalanalysis and documentation of clinical results. Thestudent will be required to write a critical evaluationof the clinical trial, a complete analysis of methodology,clinical forms, FDA regulations and data management.Grading is by S or U only. Course is eligiblefor an In Progress (IP) grade.MSM – Multiple Subject MatterMSM 301: Teaching Elementary PhysicalEducationA content course covering fundamental movementsand movement concepts, fitness and movementforms. Also addresses issues of childhood growthand development, motor learning, nutrition, basicprinciples of movement and strategies of injury prevention.MTE – Master of Education inTeachingMTE 600: Demonstrating Effective Teaching andLearning I: Assessment and PortfolioThis course serves as one of two placeholders for theBTSA experience, covering the first year of the experience.This course can only be taken when a schooldistrict does not offer the BTSA experience. Work inthis course is geared to project-based/research.MTE 601: Demonstrating Effective Teaching andLearning II: Assessment and PortfolioThis course serves as the second of two placeholdersfor the BTSA experience, covering the second year ofthe experience. This course can only be taken whena school district does not offer the BTSA experience.Work in this course is geared to projectbased/research.MTH – MathematicsMTH 012A: Beginning Algebra IFirst of a two-course sequence covering methods ofsimplifying formulas and expressions, solving equationsand inequalities, operating with exponents,and translating statements to symbols. Calculatoruse is highly recommended. Grading is S or U only.(This course is remedial in nature and does notaward collegiate credit.)MTH 012B: Beginning Algebra IICourse covers rational expressions, linear equationsin two variables, algebraic and graphical solutions ofsystems of equations, scaling and variations, quadraticand rational equations with emphasis onapplications. Grading is S or U only. (This course isremedial in nature and does not award collegiatecredit.)MTH 204: Mathematics for Science(Prerequisite: MTH 012A and MTH 012B or placementevaluation)A review of basic mathematics principles for business,probability and statistics, physical, natural, andsocial sciences for non-mathematics majors. Thiscourse provides the necessary skills to be successfulin MTH 210, MTH 215, PHS 104 and PHS 104A,CHE 101 and CHE 101A, PHS 102, SOC 100 andSOC 260.MTH 209A: Fundamentals of Mathematics I(Prerequisites: Placement evaluation)A study of the real number system and its subsystems,ancient and modern numeration systems,problem solving and simple number theory.Includes teaching materials. This is a content course,not a methods course.MTH 210: Probability and Statistics(Prerequisites: Placement Evaluation)An introduction to probability theory. Covers simpleprobability distributions, conditional probability(Bayes Rule), independence, expected value, binomialdistributions, the Central Limit Theorem, hypothesistesting, sampling and analysis of variance.Assignments may utilize the MiniTab software, ortext-accompanying course-ware STATDISK for DOSPCs. Computers are available at the University’scomputer lab. Calculator with statistical functions isrequired.MTH 214: Modeling of the Environment(Prerequisites: Placement evaluation)A course offering a thorough and useful beginninglevelunderstanding of mathematical modeling.Examines diverse applications from the physical,biological, business, social and computer sciences.Discusses the limitations, as well as the capabilities,of models applied in understanding the real worldand its inhabitants.MTH 215: College Algebra (Accelerated Course)(Prerequisite: Placement Evaluation)A continuation course in intermediate algebra.Examines higher degree polynomials, rational functions,trigonometry and matrix algebra needed formore specialized study in mathematics, computerscience, engineering and other related fields.Computer usage is encouraged. This course satisfies