The world of clinical drug trials is complex and fascinating. As an employee in this field, you’ll need an understanding of the federal regulations for approving new drugs or medical devices as well as a fundamental knowledge of human rights obligations and adverse events. From clinical trial monitoring to data collection to manufacturing, this is a field with a deep mix of science and social matters. By earning a Master of Science in Clinical Regulatory Affairs (MSCRA), you’ll gain a comprehensive knowledge of the field, develop and implement appropriate protocols and documents, and understand data management and the clinical trial research industry. You’ll also learn how to effectively file for pre-market approval, new drug approval, or biologic license approval.
Whether you need to prepare for an FDA meeting (and understand and comply with FDA audits), understand evidence-based data and data management, or coordinate and monitor clinical trials, the Master of Science in Regulatory Affairs degree will give you firm footing in this leading-edge field.
Program Learning Outcomes
- 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.
- 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 and an investigational new drug application.
- Develop compliance documents and quality assurance and quality control documentation.
Why Choose National University?
We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 165,000 alumni worldwide.
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