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MRA 604 Coordinating and Monitoring Cl

Lead Faculty: Irvin Kluth

Course Description

This course is designed to give the student comprehensive knowledge in coordinating and monitoring clinical trials and clinical trials research. Emphasis is placed on understanding regulations, good clinical practice, an overview of research, standard operating procedure, data documentation, preparing and working with subjects, monitoring clinical trials and study closure.

Learning Outcomes

  • Understand regulations affiliated with a clinical trial.
  • Understand submission of Institutional Review Boards (IRB).
  • Defined informed consent.
  • Have a fundamental knowledge of Good Clinical Practice (GCP).
  • Write a Standard Operating Procedures.
  • Assess a clinical research site.
  • Recruit and retain clinical subjects.
  • Develop and implement Case Report Forms (CRF).
  • Open and close a clinical study.
  • Define and report adverse events and monitor a study for safety.