CRMC Curriculum
Sample plan of study
There are three required and three elective courses in the Clinical Research Management certificate program. The Clinical Research Management certificate includes 12 credits of graduate coursework. Students will complete three required courses and one elective course.
These plans are for illustrative purposes only and are subject to change.
- Autumn start
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Autumn Credit Hours Nursing 7781 3 Spring MCR 7405 3 Elective* 3 Summer MCR 7770 3 Elective* 3 - Spring start
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Spring Credit Hours MCR 7405 3 Elective* 3 Summer MCR 7770 3 Elective* 3 Autumn Nursing 7781 3 - Summer start
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Summer Credit Hours MCR 7770 3 Elective* 3 Autumn Nursing 7781 3 Spring MCR 7405 3 Elective* 3
Required courses
Responsible Conduct of Research | NURS 7781 (3 credits)
This course covers concepts and policies for the responsible conduct of research (RCOR), Institutional Review Boards and dissemination of findings are introduced and analyzed in this course. (Offered: Autumn and spring semesters)
Fundamentals of Medical Product Development and Regulation | MCR 7770 (3 credits)
This course covers the 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. (Offered: Summer and autumn semesters)
Clinical Research Study and Site Management | MCR 7405 (3 credits)
Students learn 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. (Offered: Spring semester)
Elective coursework options (choose one)
Principles of Quality Management for Medical Product Development | MCR 7482 (3 credits)
This course covers concepts and application of total quality management for federal regulation of medical product development including drugs and medical devices. (Offered: Summer semester)
Project Management for Healthcare and Clinical Research | MCR 7404 (3 credits)
This course covers the principles of project management and strategic planning in healthcare, clinical research, and regulatory settings. (Offered: Summer semester)
Data Management and Informatics in Clinical Research | MCR 7481 (3 credits)
This course provides an 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. (Offered: Spring semester)