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Master of Science in Clinical Affairs

Lead Faculty: Mr. Irvin Kluth

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

  1. Employ the global regulations, standards, and GCPs involved in designing, implementing and managing clinical trials for biologics, medical devices, and drugs.
  2. Apply knowledge of human rights obligations, the clinical life cycle, and adverse events to the design of a clinical trial.
  3. Select and utilize standard biomedical clinical affairs operating policies, procedures, forms, templates, reports, and electronic records.
  4. Design a methodology for a clinical trial with supportive data management and data analysis.
  5. Write compliance documents for clinical trials.
  6. Conduct a clinical trial regulatory audit/inspection.
  7. Design and evaluate clinical trials.

Requirements

(13 courses; 58.5 quarter units)

To receive a Master of Science in Clinical Affairs, students must successfully complete at least 58.5 quarter units as required and identified in the curriculum.   A total of five (5) fully accredited courses (22.5 quarter units) maybe transferred and granted for graduate work successfully completed at another accredited institution.  Students should refer to the section on graduate admission requirements for specific information regarding application, transfer and evaluation, and graduation policies, procedures, and requirements.

Core Requirements (10 courses; 45 quarter units)

Students must choose three (3) courses, from the following list.

Core Requisite(s):

Program Electives (3 courses; 13.5 quarter units)
Students must choose three (3) courses, from the following list.