National University




Master of Science in Clinical Regulatory Affairs

Lead Faculty: Dr. Patric M. Schiltz

The Master of Science in Clinical Regulatory Affairs provides a comprehensive program of graduate study in the field of clinical trials and the federal regulations associated with developing and performing clinical trials. The program will be based on didactic lectures, case studies, and comprehensive texts and articles associated with federal government regulations and clinical trial research monitoring and coordinating. This program will allow the student to have a comprehensive knowledge of the field, develop and implement appropriate protocols and documents, as well as understand data management and the clinical trial research industry. Background Checks Clinical agencies utilized by the School of Health and Human Services may require criminal background and/or drug screening prior to acceptance of the student into the clinical facilities. Students who do not pass the criminal background check and/or drug test may be unable to attend the clinical course and therefore may be unable to complete the program of study. Any fee or cost associated with background checks and/or drug testing is the responsibility of the student.

Program Learning Outcomes

  1. Understand the federal regulations in the approval process of a new drug, medical device, or biologic;
  2. Have a fundamental knowledge of human rights obligations, adverse events, clinical trial monitoring, and data collection;
  3. Understand good clinical and manufacturing process;
  4. Develop and implement standard operating procedures, clinical data collection forms, electronic records, clinical trial protocols, and federal regulatory forms;
  5. Develop and implement a methodology for a clinical trial with supportive data management and data analysis;
  6. Design and implement an investigational device exemption;
  7. Design and implement an investigational new drug application;
  8. File for pre market approval, new drug approval, or biologic license approval;
  9. Develop compliance documents and quality assurance and quality control documentation;
  10. Prepare for an FDA meeting;
  11. Understand evidence based data and data management;
  12. Coordinate and monitor clinical trials;
  13. Understand and comply with FDA audits; and
  14. Be proficient in statistical analysis of clinical results

Requirements

(11 courses; 49.5 quarter units)

To receive a Master of Science in Clinical Regulatory Affairs, students must successfully complete at least 49.5 quarter units as required and identified in the curriculum.   A total of nine (9) 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.

Degree Requirements (11 courses; 49.5 quarter units)