Contact

Request Information

Please complete the form below, and an admissions advisor will contact you shortly.

800-628-8648

Apply Now

Ready to take the next step?

The application process is easy. We accept and review applications year-round, and qualified applicants can begin classes any month of the year, depending on your program and location.

Click Apply Now to get started on the next exciting chapter of your life!

Apply Now

MRA 610B Regulatory Affairs Internship

Lead Faculty: Mr. 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.