All classes are offered evenings and weekends at the SCSU Twin Cities Graduate Center in Maple Grove, Minnesota. The program can be completed in six semesters over two years or on a part-time basis. Click here to access the Full Course Catalog.
This course examines the major human organ systems. An overview of basic cellular structure and function and metabolism will also be taught. Information learned is applied to the development of medical devices and combination products to diagnose, mitigate or cure pathological conditions. Students will demonstrate their ability to independently learn new topics through class presentations. Credits: 4
This course describes the role that clinical research professionals contribute in the various phases of the medical product development life cycle. It provides a broad overview of knowledge and experience that clinical research professionals must acquire to be successful in the medical technology field. Credits: 2
A non-calculus based introduction to a wide variety of statistical tools used in the design, monitoring, and analysis of clinical studies. The course will be rooted in FDA and ICH guidance and require students to perform and interpret non-trivial calculations to better illumine the subject matter. Credits: 4
This course presents an overview of published clinical experience, primarily the practice and principles of evidenced-based medicine relating to common chronic diseases and conditions. The relationship between this published experience and the role of medical devices and combination products will covered through case study examples.
Upon completion of this course the masters student will be knowledgeable about the regulations associated with research ethics, regulatory and global standards for research conduct and how to problem solve real-world cases. The student will also be aware of other considerations associated with how and when different research regulations and standards apply to various clinical trials. Effective communication and ethical considerations when handling negative product performance situations. Credits: 3
This course provides a detailed understanding of clinical research topics and techniques used to plan for clinical research trial. Specific topics include protocol development, study design selection, budgeting, investigational plan requirements and site selection, etc. Legal and regulatory aspects of clinical research planning will also be covered. Credits: 3
This course provides an overview of the key operational components for conducting a clinical device study including an overview of the roles and responsibilities of practitioners. Study tracking tools and strategies for clinical project management will be incorporated through the course. Prerequisite: ACR-630 Credits: 3
Regulations and expectations related to risk analysis, mitigation, assurance, and control in clinical trials. Structuring clinical quality controls, manage issues, Corrective and Preventive Actions (CAPA), manage adverse events, protocol deviations, and safety issues as well as facilitate medical advisory and safety committees. Credits: 3
This course provides an overview of the regulatory reporting requirements related to the clinical research of medical products. Communication skills and approaches as well as the required documentation to regulatory bodies are included. Clinical reporting examples will be analyzed and the knowledge gained will be applied to a project. Credits: 3
This course provides an overview of clinical research leadership in an industry setting and key roles and responsibilities in carrying out the scope of leadership responsibilities. Topics will cover clinical leadership in the integration of cross-functional objectives and the application of critical thinking. Credits: 3
This course covers the fundamental skills for success in the MedTech programs and professions. Utilizing examples relevant to the medical device industry the topics covered in the course include medical writing, persuasive writing, professional presentations, self-awareness, as well as giving and receiving feedback Credits: 1
The Clinical Culminating Experience will consist of three parts: a research paper demonstrating integration and understanding of information acquired in at least three courses, a comprehensive written examination covering clinical research regulations (guidelines and standards) and an oral examination demonstrating clinical research leadership and critical thinking. With instructor and administrative review and approval, students may also carry out a research project to demonstrate their understanding of applied clinical research. Prerequisite: This course can be started earlier but cannot be completed before the final semester of the program. Credits: 3