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 federal regulations associated with this endeavor. 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, to develop and implement appropriate protocols and documents, understand data management, and become certified in the clinical trial research industry. The target market for this program is multifold:

• Those students with a bachelor's degree in a science field and wish to obtain an advance degree which will lead them to a career in regulatory affairs.
• Those students who are already in the field of regulatory affairs but do not have the credentials to further advance their careers.
• Those students who wish to move within their companies to a regulatory affairs position.

All of the above candidates will have greater opportunities in the healthcare field and will have marked improvement in their career salaries.

Program Outcomes
Upon completion, the candidates will be able to:

• Understand the federal regulations in the approval process of a new drug, medical device, or biologic
• Have a fundamental knowledge of human rights obligations, adverse events, clinical trial monitoring, and data collection
• Understand good clinical manufacturing process
• Develop and implement standard operating procedures, clinical data collection forms, electronic records, clinical trial protocols, and federal regulatory forms
• Develop and implement a methodology for a clinical trial with supportive data management and data analysis
• Design and implement an investigational device exemption
• Design and implement an investigational new drug application
• File for pre-market approval, new drug approval, or biologic license approval
• Develop compliance documents and quality assurance and quality control documentation
• Prepare for FDA meeting
• Understand evidence based data and data management
• coordinate and monitor clinical trials
• Understand and comply with FDA audits
• Be proficient in statistical analysis of clinical results

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.

Requirements

Degree Requirements (11 courses; 49.5 quarter units)
MRA 600 - Introduction to Regulatory Affairs
MRA 601 - Clinical Documentation
MRA 602 - Human Subjects in Clinical Trials
HCA 609A - Healthcare Law, Policy, Politics, and Ethics
HTM 605 - Helathcare Information Technologies
HCA 605 - Evidence Based Healthcare
MRA 603 - Medical Device and Pharmaceutical Regulations
MRA 604 - Coordinating and Monitoring Clinical Research
MRA 605 - Analytical Methods for Regulatory Affairs
MRA 606 - FDA Regulations and Submissions
MRA 610A - Research Capstone Project in Regulatory Affairs
or
MRA 610B - Regulatory Affairs Internship

Program Information

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Program Locations

• Technology and Health Sciences Center