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Learn how to meet regulatory oversight requirements as they relate to the conduct of clinical studies with the MS degree in clinical research management.
The purpose of the regulatory science concentration is to prepare students for careers in regulatory aspects of clinical research. The regulatory science program uses a transdisciplinary approach and encompasses coursework in regulatory writing techniques, quality systems and medical device or pharmaceutical regulation. The concentration program is designed to develop the student's understanding of how to meet regulatory oversight requirements as they relate to the conduct of clinical studies. The program offers an alternative course option for students pursuing the clinical research management MS degree.
Clinical Research Management (Regulatory Science), MS
College of Nursing and Health Innovation
The Plan of Study is the required curriculum to complete the program.
The following dates are for the 2017-2018 academic year.
Applications are prioritized by student qualifications and date of application with early applications receiving higher priority. Admission for each semester will be limited to 30 students.
Required Core (15 credit hours)
HCR 551 Clinical Research Monitoring (3)
HCR 561 Responsible Conduct of Clinical Research (3)
HCR 563 Fundamentals of Regulatory Affairs (3)
HCR 565 Clinical Research Operations (3)
HCR 574 Scientific and Research Review Boards (3)
Concentration Courses (15 credit hours)
HCR 552 Medical Device Development and Regulation (3)
HCR 553 Quality Assurance and Clinical Research (3)
HCR 555 Pharmaceutical Safety and Risk Management (3)
HCR 558 Technical Writing for the Regulatory Professional (3)
HCR 562 Clinical Research Data Management and Technology Implementation (3)
Culminating Experience (3 credit hours)
HCR 566 Capstone Clinical Research Management Project II (3)
Students taking the Clinical Research Management Certificate may transfer up to 9 credit hours into the degree program if they are admitted to the MS degree before completing the 9th credit. Students who have already completed the Clinical Research Management Certificate may be eligible to transfer 9 credits from the certificate program to the degree program. These students must complete an additional 3-credit capstone project and 3 additional elective credits, as well as courses specific to the MS degree.