Regulatory Affairs Internship

Course Description

This course is designed to give the student a “hands on” real world experience working in a clinical trial environment. The student will acquire fundamental knowledge in evidence based clinical data, statistical analysis and documentation of clinical results. The student will be required to write a critical evaluation of the clinical trial a complete analysis of methodology, clinical forms, FDA regulations and data management. Grading is by S or U only. Course is eligible for an “IP” grade.

Learning Outcomes

• Understand the implementation of protocol in a clinical trial.
• Evaluate evidence based clinical data.
• Develop a data management system with clinical trial outcomes.
• Understand all documentation used in the clinical trial for FDA approval.
• Design clinical report forms, standard operating procedures, compliance documentation IRB submittals and all other documents necessary for FDA approval.
• Understand the FDA regulations as related to the clinical trial.
• Understand audits and adverse events.
• Be familiar with content and preparation for FDA meetings.