Master of Applied Clinical and Preclinical Research Curriculum and Course Descriptions

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1 Program Description and Curriculum: For more information, please visit: The (MACPR) program prepares graduates to excel as effective administrators, regulatory compliance specialists, and research team members in clinical and preclinical research. The program offers a multidisciplinary curriculum, covering the theory and practice of research methods and statistics, the ethics of human subject and animal research, the science of pharmacology and medical product regulation, and the business of research operations and management. Graduates will have acquired the skills and knowledge required to conduct, manage, and regulate clinical and preclinical trials. The degree program is offered entirely online through a collaboration of the Colleges of Nursing, Pharmacy, and Medicine. The target audience includes applicants with any undergraduate degree and is particularly well suited for graduates with a degree in the biological/life sciences or pharmaceutical sciences, health care professionals, and those with graduate degrees in the biomedical sciences seeking to diversify their training. Four interdisciplinary specializations are offered: 1. Clinical Research (directed by the College of Nursing) 2. Regulatory Affairs (directed by the Colleges of Nursing and Pharmacy) 3. Safety Pharmacology (directed by the College of Pharmacy) 4. Clinical Pharmacology (directed by the College of Pharmacy and the Dept. of Pharmacology, College of Medicine) Core Courses (common to all specializations; 18 credits required) Pharmacology course (for students without prior pharmacology coursework at the graduate or upper undergraduate level) Option 1: Pharmacology 5600: Option 2: Pharmacy 5010 Introduction to General Pharmacology Fundamentals of Pharmacology (for CRM and RA students only) Nursing/Pharmacy 7770: Fundamentals of Medical Product Development and Regulation Research Ethics course Bioethics 6010: Nursing 7781: Biomedical Research Ethics (for students in the SP and CP specializations) Responsible Conduct of Research (for students in the CRM and RA specializations) Nursing/Pharmacy 7782: Research Design and Methods for Clinical and Preclinical Research Nursing/Pharmacy 7405: of Clinical and Preclinical Studies PUBHBIO 6210: Design and Analysis of Studies in the Health Sciences I (biostatistics) Specialization Courses (additional 15 credits required) Clinical Research Regulatory Affairs Safety Pharmacology Clinical Pharmacology Nursing 7404: Clinical Research Project and Leadership Nursing/Pharmacy 7460: Regulatory Strategy, Writing, and Leadership Pharmacy 7580: Principles of Safety Pharmacology Pharmacy 7582: Nursing 7481: Data and Informatics in Clinical Research Nursing 7482: Prin. of Quality for Medical Product Dev. Nursing 7402: Economic Evaluation of Healthcare Interventions Intro. to Person. Therap. and Nursing/Pharmacy 7482: Prin. of Quality for Medical Product Dev. Pharmacy 7572: Global Regulation of Medical Products Nursing 7481: Data and Informatics in Clinical Research Pharmacy 7580: Principles of Safety Pharmacology (Internship/Project) ( required) Nursing 7599: Nursing/Pharmacy 7599: Pharmacy 7582: Pharmacy 7584: Applied Pharmacokinetics and Pharmacodynamics Pharmacy 7586: Integrative In Vivo Modeling for Drug Dev.: Application for Safety & Clinical Pharmacology Select one: Intro. to Person. Therap. and Pharmacy 7599: Pharmacy 7584: Applied Pharmacokinetics and Pharmacodynamics Pharmacology 7550: Research Applications of Clinical Pharmacology Intro. to Personalized Therapeutics and Pharmacology/Pharmacy 7599: Page 1 of 5

2 Course Descriptions: Please note: All courses will be offered online only unless otherwise specified. CORE COURSES Pharmacology course Option 1: Pharmacology 5600 Autumn// Option 2: Pharmacy 5010 Nursing/Pharmacy 7770 Autumn/ Research Ethics course SP and CP specializations: Bioethics 6010 Autumn/ online CRM and RA specializations: Nursing 7781 Autumn/ online, face-to-face as needed Nursing/Pharmacy 7405 / Nursing/Pharmacy 7782 Autumn/ Required for students without prior pharmacology coursework at the graduate or upper undergraduate level. Please register for the section for graduate students and is Distance Learning/Online delivery. Contact the program coordinator if you encounter any difficulty. Introduction to General Pharmacology Introductory course emphasizing the general principles of pharmacology using a systems-based and mechanism-based approach. The course provides a simple overview of the subject. (Note: this course is more science-focused than Pharmacy 5010 and is best suited for students who have completed physiology or pathophysiology and a college level chemistry or biochemistry course.) Prerequisites: chemistry and physiology. Fundamentals of Pharmacology (for CRM and RA students only) This course presents an overview of basic principles underlying drug action. Not open to students with credit for Pharmacy 4400, Pharmacology 5600, or HTHRHSC 5510 Fundamentals of Medical Product Development and Regulation Function of clinical research in medical product development and the regulatory process of new medical products. Laws and regulations concerning the development, testing, commercialization, and total product life cycle for medical products. Regulations governing the conduct of clinical research, including study sponsors, investigators, and Institutional Review Boards. Biomedical Research Ethics The broad intent of this course is to highlight the importance of ethics in biomedical research and to explore how critical ethical thinking can be used to analyze personal decision-making, public regulation, and the law concerning advanced biomedical sciences/technologies and their clinical applications. Responsible Conduct of Research Concepts and policies for the responsible conduct of research (RCOR), Institutional Review Boards, and dissemination of findings. of Clinical and Preclinical Studies Fundamental principles of clinical research operations from study site selection to study closure from the perspective of sponsors and clinical research sites including an introduction to database design, management, quality assurance and reporting for site and sponsor operations. Prerequisite: Nursing/Pharmacy Research Design and Methods for Clinical and Preclinical Research Study of research design and methods used in clinical and preclinical research. Measurement issues, bias and confounding, statistical considerations, evaluation of published clinical and preclinical research designs, and protocol and proposal development. Page 2 of 5

3 PUBHBIO 6210 Autumn/ SPECIALIZATION COURSES Nursing 7402 Nursing 7404 Nursing 7481 Autumn Nursing 7482 Nursing/Pharmacy 7460 Pharmacology 7550 Pharmacy 7570 Autumn Design and Analysis of Studies in the Health Sciences I Theory and application of basic statistical concepts for design of studies in health sciences, integrated with statistical software applications. Prerequisite: permission of instructor. Economic Evaluation of Healthcare Interventions Introduction to economic evaluation of healthcare interventions and services, including evaluating costs and health outcomes, using results to inform resource allocation, interpretation and evaluation of economic evaluations in the literature, and decision analysis in healthcare. Elective in Clinical Research specialization. Prerequisite: none. Healthcare and Clinical Research Project and Leadership Principles of project management, strategic planning, and leadership in healthcare, clinical research and regulatory settings. Requirement in Clinical Research specialization. Prerequisite: Nursing/Pharmacy Data and Informatics in Clinical Research Introduction to fundamental principles of clinical research data management and informatics to include the acquisition and management of data during clinical research studies, including source data, data entry, data quality assurance, reporting, and security. Requirement in Clinical Research specializations. Elective in the Regulatory Affairs specializations. Prerequisite: Nursing/Pharmacy Principles of Quality for Medical Product Development Concepts and application of total quality management for federal regulation of medical product development including drugs and medical devices. Requirement in Clinical Research and Regulatory Affairs specializations. Prerequisite: Nursing/Pharmacy Regulatory Strategy, Writing, and Leadership Explores regulatory strategy and the variety of roles of regulatory professionals in new healthcare product development. Scholarly and technical writing skills for regulatory professionals for new product submissions and FDA Advisory Panels. Principles of strategic planning, leadership, communication and team building. Requirement in Regulatory Affairs specialization. Prerequisite: Nursing/Pharmacy Research Applications of Clinical Pharmacology Introduction and review of basic and advanced concepts in pharmacology for clinical pharmacologists. Overview of pharmacologic principles underlying the individualization of drug therapy and contemporary drug development. Fundamentals of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products. Requirement in Clinical Pharmacology specialization. Prerequisite: Pharmacology 5600 or Pharmacy 5010; Pre-/Co-requisite: Pharmacy Comprehensive investigation of pharmacovigilance initiatives and pharmaceutical safety regulation. Pharmaceutical risk management in premarket testing and development, recognition of safety signals, post-approval experience, drug production, risk mitigation, and administration of pharmaceuticals. Requirement in Regulatory Affairs specialization. Elective in Clinical Research, Safety Pharmacology, and Clinical Pharmacology specializations. Prerequisite: Nursing/Pharmacy Page 3 of 5

4 Pharmacy 7572 Pharmacy 7580 Pharmacy 7582 Pharmacy 7584 Pharmacy 7586 HTHRHSC credits Autumn/ Pharmacology credit CAPSTONE Nursing/Pharmacy/Pharmacology credits min. 3 total required Autumn// Global Regulation of Medical Products Exploring legal issues related to clinical research and regulatory affairs. Examining the role of regulatory authorities, regulations and guidelines (US, EU and global) in new product development. Requirement in Regulatory Affairs specialization. Prerequisites: Nursing/Pharmacy Principles of Safety Pharmacology Introduction to organ system studies of current experimental models, risk assessment, and regulatory guidelines for evaluating drug candidates in various organ systems. Requirement in Safety Pharmacology Specialization. Elective in Regulatory Affairs specialization. Prerequisites: Pharmacology 5600 or HTHRHSC The course covers principles of toxicology, physiology and pharmacology as they relate to adverse and unanticipated drug effects, with emphasis on cardiovascular, brain, pulmonary, liver, and kidney systems. Requirement in Safety Pharmacology and Clinical Pharmacology Specializations. Prerequisites: Basic pharmacology course recommended (e.g., Pharmacy 4400, Pharmacy 5010, or Pharmacology 5600). Applied Pharmacokinetics and Pharmacodynamics This course will introduce students to the concepts of pharmacokinetics (PK) and pharmacodynamics (PD) and demonstrate how these concepts are applied in preclinical and clinical research for the development of safe and effective new drug therapies. Case studies demonstrating how PK/PD is applied throughout the drug development process. Requirement in Safety Pharmacology and Clinical Pharmacology specializations. Prerequisite: Pharmacy 4400, Pharmacy 5010, or Pharmacology Integrative in Vivo Modeling for Drug Development: Application for Safety and Clinical Pharmacology Evaluating drug effects and animal models for safety and toxicity assessment. Prerequisite: Pharmacology 5600, Pharmacy 7580, and Pharmacy Introduction to Pathophysiology How disrupting normal structures and functions of the human body leads to development of disease processes from the cellular to the multi-system level. Explanation of the major concepts of pathophysiology including etiology, signs, symptoms, diagnosis, treatment and complications of major body system disorders. Elective in Clinical Research, Safety Pharmacology, and Clinical Pharmacology specializations. Prerequisites: physiology. Introduction to Personalized Therapeutics and Exploration of the trend to therapy tailored to the individual patient rather than one drug fits all; inter-individual differences in drug responses, with emphasis on genetic and genomic factors; ethical, regulatory and economic issues that impact drug therapies. Elective in Clinical Research, Safety Pharm., and Clinical Pharm. Spec. Prerequisite: Introductory biology course recommended. Culminating project and/or practicum (3 hrs/credit hr/week over 15 weeks). project or practicum for students in the master s program in Applied Clinical and Preclinical Research. Culminating learning activity integrating core and specialization coursework. project or practicum performed at an organization involved with clinical or preclinical research with the oversight of a faculty advisor and site mentor. Prerequisite: completion of all required coursework in specialization Page 4 of 5

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