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Course Descriptions |
| CR 500S EPIDEMIOLOGY - 3.00 credits |
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| Epidemiology is at the core of research professions as it is the study of the distribution, determinants, and the course of health related events in populations, and the efficacy and effectiveness of prevention and intervention strategies. |
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| CR 501S Emerging Trends in Medical Device History - 3.00 credits |
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| The goal of this course is to focus on the various trends that impact the research and development process inherent in the medical device industry. Case studies representing several therapeutic categories will be discussed from a business, medical scientific, ethical, regulatory and bio-medical engineering perspective |
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| CR 505S ETHICAL ISSUES IN RESEARCH - 3.00 credits |
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| Students explore ethical issues to sound clinical research, review the foundations of regulations for clinical investigations, and to better understand the operational imperatives of Good Clinical Practices. |
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| CR 511S The History of Misconduct in Biomedical Research - 3.00 credits |
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| CR 512S Fundamentals of Academic Research Administration - 3.00 credits |
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| This course examines the operation of the research administration organization in the academic health care environment. Included will be a series of discussions focusing on the role of administration's leadership, development function, management, and support of the research enterprise in protecting and preserving the institution's interests through the examination of case studies. |
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| CR 515S INTRO TO CLINICAL TRIALS - 3.00 credits |
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| This course introduces regulatory responsibilities of clinical investigators, sponsors, monitors, IRBs, FDA -all those parties intimately involved in clinical research. Information and exercises are designed to reinforce the elements of Good Clinical Practices. |
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| CR 520S Applications of Clinical Research Biostatistics - 3.00 credits |
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| Examines role of the statistician in clinical research. Course includes a discussion of the language of statistics to facilitate communication with the clinical research project team, basic methods of describing data, fundamentals of probability, simple models and methods of parameter estimation and statistical software packages for reporting data. |
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| CR 525S SCIENTIFIC WRITING & MED LIT - 3.00 credits |
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| This course teaches the medical professional the ability to read for understanding, and evaluate validity of information a medical or scientific paper. In addition, the student learns how to recognize various types of medical literature and the basics of how to perform a review of the medical literature. |
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| CR 535S Current Federal Regulatory Issues in Biomedical Research - 3.00 credits |
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| CR 545S PHARMACEUTICAL LAW - 3.00 credits |
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| Presents principles and practices of the Federal Food, Drug and Cosmetic Act governing the research and development of pharmaceuticals and biologics for both humans and animals including an analysis of legal and social constructs affecting industry and the academic clinical investigator with emphasis on FDA enforcement actions. |
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| CR 555S COMPLIANCE & MONITORING ISSUES - 3.00 credits |
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| This course focuses on measuring and improving clinical trial performance as a means of saving time and money, while ensuring quality health care, as well as offering to patients both safe and effective therapeutic products. Students are required to develop milestone efficiencies through the use of process-performance data. |
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| CR 565S Contemporary Issues in Human Research Protection - 3.00 credits |
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| CR 570S Principles and Practice of Pharmacovigilance - 3.00 credits |
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| This course is an introduction to the ethical, clinical, and regulatory complexities of medication safety and matters thinking skills for improving the quality and effectiveness of drug safety monitoring for both the pharmaceutical industry and its impact on the public. |
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| CR 600S DESIGNING THE CLINICAL TRIAL - 3.00 credits |
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| Designers and ethical, clinical, strategic issues surrounding clinical drug research are the focus of this course. Topics include design of trials for Phases one though four, an overview of the statistical component of a clinical trial, monitoring of the trial, and managing clinical data. |
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| CR 609S INNOVATIVE PRODUCE DEVELOPMENT - 3.00 credits |
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| This comprehensive course provides a solid foundation in new therapeutic product research and development for the subsequent courses in the CROM program. This course focuses on the process of drug and medical device development from early research, discovery, and product formulation, through the federal requirements form proving safety and efficacy. May be repeated twice for credit. |
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| CR 612S FUNDAMENTALS OF COMPLIANCE - 3.00 credits |
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| The study of the federal bodies and regulations that govern research. Topics include: the rules and regulations surrounding HIPAA and how it affects research on human subjects, the history and current role of the FDA, IACUC, and the IRB within the research arena. May be repeated twice for credit. |
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| CR 614S Pharmacotherapy in New Drug R&D - 3.00 credits |
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| Through the use of selected readings, case studies available from the FDA, and Blackboard discussions, this course will integrate preclinical/clinical research pharmaceutical operations along with federal regulatory approval principles, emphasizing the essentials of pharmacokinetic /pharmacodynamic activity of medications as the sound basis for understanding the clinical application of drug therapy with specific populations. |
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| CR 616S Intro to Therapeutic Products - 3.00 credits |
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| This course is designed to provide an overview of the diverse marketing and advertising practices and strategies of the pharmaceutical industry and their impact on the professional healthcare infrastructure, as well as on the healthcare recipient population. Students will be encouraged to develop skills to crucially evaluate the marketing techniques of the pharmaceutical industry. |
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| CR 617S Informatics in Pharm Res & Development - 3.00 credits |
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| Using a combination of printed materials, case studies, literature reviews, and on-line discussions, this course will cover past and present contributions of computer applications in pharmaceutical research and development. In addition, the student will be challenged to portend where technological advances may prove to be strategically beneficial in the future. |
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| CR 620S BIOTECH/RESEARCH - 3.00 credits |
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| The study of the history, use and progression of biological techniques developed through basic research and now how it is applied to research and product development. |
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| CR 625S HEALTH POLICY AND ECONOMICS - 3.00 credits |
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| The study of the development, analysis and communication of economic data in the context of clinical research. May be repeated twice for credit. |
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| CR 633S QUALITY ASSURANCE AUDITS - 3.00 credits |
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| This course provides the student with an in-depth knowledge of compliance and quality assurance issues as well as the related regulations inherent in the drug development process. Students develop auditing plans and strategies for conducting compliance inspections. |
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| CR 635S STRATEGIC PLANNING - 3.00 credits |
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| This course introduces the student to the project management and planning process. Topics include: project communications, leadership, objectives, scope, success criteria, procurement, cost estimating, control mechanisms, developing mission statements and devising strategies that turn vision into reality. May be repeated twice for credit. |
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