The Master of Science in Clinical Affairs provides a comprehensive program of graduate study in the need, design, implementation and management of clinical trials from the biomedical industry perspective. In particular, it focuses on global regulations, standards and statutes which are necessary for designing, developing, obtaining approval, performing, and reporting on clinical trials. The program will be based on lectures, case studies, research and comprehensive texts and articles associated with the global biomedical industry, regulatory agencies, and governmental authorities who are engaged in clinical trial research monitoring, coordination and compliance. This program will prepare the student with a comprehensive academic and practical knowledge of the field; an understanding of the clinical life cycle, data management, and critical role that clinical trial research plays in the development and commercialization of biologic, device and drug products; and the skills needed to develop and implement appropriate protocols and documents.
Program Learning Outcomes
- Employ the global regulations, standards, and GCPs involved in designing, implementing and managing clinical trials for biologics, medical devices, and drugs.
- Apply knowledge of human rights obligations, the clinical life cycle, and adverse events to the design of a clinical trial.
- Select and utilize standard biomedical clinical affairs operating policies, procedures, forms, templates, reports, and electronic records.
- Design a methodology for a clinical trial with supportive data management and data analysis.
- Write compliance documents for clinical trials.
- Conduct a clinical trial regulatory audit/inspection.
- Design and evaluate clinical trials.
- CAF 600 Clinical Research Survey
- CAF 605 Good Clinical Practice (GCP)
- CAF 615 CAF Data Mgmt & Statistics
- CAF 621 CAF Ethics & Pharmacivigilance
- CAF 635 Clinical Trial Design
- CAF 645 CAF Communications
- CAF 650 Clinical Operations Part 1
- CAF 651 Clinical Operations Part 2
- CAF 660 Clinical Trial Project Mgmt
- CAF 699A Capstone Thesis Option
- CAF 699B Capstone Project Option
- CAF 699C Capstone Internship Option
- CAF 699D Capstone Comprehensive Exam