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CAF699D Capstone Comprehensive Exam

Lead Faculty: Mr. Irvin Kluth

Course Description

This course is designed to have the student study and prepare for a comprehensive final "Clinical Affairs" degree program examination that integrates all facets of "clinical affairs" including regulations, documentation, clinical evidence, data management, statistical analysis of the data and other principles taught throughout the entire program.

Learning Outcomes

  • Select global regulations, standards and statutes that apply to biomedical clinical affairs including Good Clinical Practices (GCPs).
  • Argue the proper global regulations, standards and statutes that apply to clinical affairs and clinical trials.
  • Contrast the roles and responsibilities of those involved in clinical trials.
  • Examine frequent issues and problems encountered by clinical affairs personnel.
  • Defend responses to real-life issues and problems encountered by clinical affairs personnel.