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MRA 610B Regulatory Affairs Internship

Lead Faculty: Dr. Patric M. Schiltz

Course Description

This course is designed to give the student a "hands on" real workd 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 students 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 In Progress (IP) grade.

Course Information