Curriculum
This program requires the successful completion of three required courses and any two electives for a total of 15 credits. With the assistance of a curriculum advisor, students will choose from a variety of specialized courses depending on their educational objectives and employment-related experiences. Graduate credit will not be given for work-related experience.
Course Descriptions
CR515: Introduction to Clinical Trials
This course will provide the student with an opportunity to learn and understand the regulatory and scientific rationale of designing, conducting, and successfully completing a clinical trial. Also, the essential documents required to conduct a clinical trial will be introduced as well as critical issues to be considered when designing a protocol for a clinical study. This course is vital to understanding and applying the principles and practices for designing and conducting a quality research program within the prescribed federal regulatory framework.
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CR525: Scientific Writing & Interpretation of Medical Literature
This course will examine the rhetorical and scientific principles involved in writing in the sciences, using narrative structures, theories of discourse, linguistic principles, and fundamental biomedical and scientific data. In addition, this course will show students how to research and evaluate information, summarize and organize clinical and technical data, prepare concise and lucid documents within the constraints of regulatory and other procedural requirements.
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CR545: Pharmaceutical Law in R&D
This course will introduce several legal and regulatory principles and practices under the Federal Food, Drug and Cosmetics Act governing the research and development of pharmaceuticals and biologics in human and animal research. Students will analyze legal and social constructs affecting industry and the academic clinical investigator, with particular attention on FDA regulatory and enforcement actions. Pharmaceutical law will provide the backdrop for the majority of courses in the CROM program.
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CR565: Contemporary Issues in Human Research Protection
This course will examine and analyze various case-based topics focusing on specific ethical policies, federal regulations, and the legal practices of quality clinical research with particular attention to the institutional review board, the informed consent process, and common mechanisms in place to ensure the adequate protection of the human research participant.
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CR570: Principles and Practice of Pharmacovigilance
This course will review historical and contemporary safety reporting parameters, pre-approval clinical testing, and an examination of the various agencies assessing and monitoring risk management, real-world issues and controversies in order understand the importance of drug safety.
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CR609: Innovative Product Development
This course focuses on the process of drug development from early research, discovery, and product formulation, through the federal requirements from proving safety and efficacy. To demonstrate the application of these goals, the student will be expected to develop a business profile of a company.
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CR612: Fundamentals of Compliance
This course will provide the values and responsibilities of the clinical investigator as they relate to the discipline of science and to society beyond clinical research. There will be a fundamental integration of the concepts for the responsible conduct of research, its subject matter and understanding, including such topics as research integrity, environmental and safety issues, institutional and organizational fiscal contractual accountability, and the development of the clinical trial site budget.
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CR620: Principles, Practice, and Regulation of Biotechnology
This course will provide an overview of the history of biotechnology and the fundamental scientific concepts for developing marketable medical therapeutic products through the integration of science and marketing.
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CR625: Health Policy and Economics
This course will begin with an exploration of the dynamic environment of health care and the processes of healthcare delivery in the managed care environment. Also, there will be a review of cost containment practices and the economic methodologies employed to evaluate the cost effectiveness of healthcare services. Cost effectiveness will be examined in terms of outcome assessments and quality of life measurements.
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