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MRA 610B Regulatory Affairs Internship

Lead Faculty: Irvin Kluth

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.