Catalog 73 - National University

School of Health and Human ServicesProgram Learning OutcomesUpon successful completion of this program, students will be able to:• Understand the federal regulations in the approval process of anew drug, medical device, or biologic;• Have a fundamental knowledge of human rights obligations,adverse events, clinical trial monitoring, and data collection;• Understand good clinical and manufacturing process;• Develop and implement standard operating procedures, clinicaldata collection forms, electronic records, clinical trial protocols,and federal regulatory forms;• Develop and implement a methodology for a clinical trial withsupportive data management and data analysis;• Design and implement an investigational device exemption;• Design and implement an investigational new drug application;• File for pre market approval, new drug approval, or biologiclicense approval;• Develop compliance documents and quality assurance andquality control documentation;• Prepare for an FDA meeting;• Understand evidence based data and data management;• Coordinate and monitor clinical trials;• Understand and comply with FDA audits; and• Be proficient in statistical analysis of clinical resultsBackground ChecksClinical agencies utilized by the School of Health and HumanServices may require criminal background and/or drug screeningprior to acceptance of the student into the clinical facilities.Students who do not pass the criminal background check and/ordrug test may be unable to attend the clinical course and thereforemay be unable to complete the program of study. Any fee or costassociated with background checks and/or drug testing is theresponsibility of the student.Degree Requirements(11 courses 49.5 quarter units)MRA 600 Introduction to Regulatory AffairsMRA 601 Clinical DocumentationMRA 602 Human Subjects in Clinical TrialsHCA 609A Healthcare Law, Policy, Politics and EthicsHTM 605 Healthcare Information TechnologiesHCA 605 Evidence Based HealthcareMRA 603 Medical Device and Pharmaceutical RegulationsMRA 604 Coordinating and Monitoring Clinical ResearchMRA 605 Analytical Methods for Regulatory AffairsMRA 606 FDA Regulations and SubmissionsMRA 610A Research Capstone Project in Regulatory AffairsorMRA 610B Regulatory Affairs InternshipCERTIFICATE PROGRAMS● LVN “30 UNIT” OPTION CERTIFICATE(670-000-184)Licensed vocational nurses (LVNs) who desire to complete theminimum number of units required to take the licensureexamination may apply for this option. LVNs who select the “30-Unit Option” method to satisfy the requirements for licensure as aRegistered Nurse should consult the Chair of the Department ofNursing for an individual program consultation to discuss theadvantages and disadvantages of this option.Departmental Admission RequirementsTo be eligible for admission to the “30 Unit” certificate, candidatesmust satisfy all of the following criteria:• Have completed the National University undergraduateadmission process• Hold a current, active license to practice as a licensed vocationalnurse• Have successfully completed the required preparation courses• Submit the appropriate nursing program application• For advising purposes only, complete the ACCUPLACER mathand English testsAfter completing the interview process, successful candidates willbe enrolled in classes as spaces become available.Requirements for the CertificateTo receive the “30 Unit Option” certificate, students must completethe 39 quarter units as outlined below. The following courses arespecific certificate requirements.Required Preparation(4 courses; 12 quarter units)BIO 202BIO 202ABIO 203BIO 203AHuman Anatomy & Physiol II(Recommended: prior completion of BIO 201 & 201A,100 & 100A, CHE 101 & 101A, or equivalent courses)Human Anatomy & Physiol Lab II 1.5 quarter units)(Prerequisite: BIO 202)Introductory Microbiology(Recommended: prior completion of BIO 201 & 201A,BIO 202 & 202A, BIO 100 & 100A, CHE 101 & 101A, orequivalent courses)Introductory Microbiology Lab (1.5 quarter Units)(Prerequisite: BIO 203)Nursing Core Courses(6 courses; 27 quarter units)NSG 310 Professional Nursing Values**NSG 320 Medical-Surgical Nursing II**NSG 320A Medical-Surgical II Clinical **NSG 325 Psychosocial Nursing**(Prerequisite: “C” or better in NSG 320 and “S” in NSG320A)NSG 325A Psychosocial Nursing Clinical **(Prerequisite: “C” or better in NSG 320 and “S” in NSG320A)NSG 342 Nursing Leadership/Management**(Prerequisite: “C” or better in NSG 325 and “S” in NSG325A)** Content required for licensure by CA Board of RegisteredNursing● HEALTH COACHING CERTIFICATE(770-791)Faculty Advisor: Patric Schiltz • (858) 309-3476 • pschiltz@nu.eduThis certificate is designed for integrative health professionalsseeking to extend and improve their ability to coach patientsthrough lifestyle and health changes. Potential students includephysicians, nurses, chiropractors, nutritionists, pharmacists,acupuncture practitioners, naturopathy practitioners, physicalfitness trainers, weight management coaches, and physicaltherapists, among others.276