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

Upon successful completion of this program, students 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 and manufacturing process;
• Develop and implement standard operating procedures, clinical data collection forms, eectronic 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 an FDA meeting;
• Understand evidence based data and data management;
• Coordinate and monitor clinical trials;
• Understand and comply with FDA audits; and
• 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 degree, students must complete at least 49.5 quarter units of graduate work. A total of 9 quarter units of graduate credit may be granted for equivalent graduate work completed at another institution, as it applies to this degree and provided the units were not used in earning another advanced degree. Refer to the section on graduate admission requirements for specific information regarding application and evaluation.

Core Requirements (11 courses 49.5 quarter units)
MRA 600 Intro to Regulatory Affairs
MRA 601 Clinical Documentation
MRA 602 Human Subjects in Clinical Tri
HCA 609A Healthcare Law, Policy, Politi
HTM 605 Healthcare Info Technologies
HCA 605 Evidenced Based Healthcare
MRA 603 Medical Device and Pharmaceuti
MRA 604 Coordinating and Monitoring Cl
MRA 605 Analytical Methods for Regulat
MRA 606 FDA Regulations & Submissions
MRA 610A Regulatory Affairs Capstone
or
MRA 610B Regulatory Affairs Internship

Program Information

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Program Locations

• Technology and Health Sciences Center