CAF660 Clinical Trial Project Mgmt

Lead Faculty: Irvin Kluth

Course Description

This course provides the student with an in-depth foundation in project management principles and tools for managing clinical trials from initiation through trial close-out and archiving. There will be detailed exploration, identification, and discussion of all aspects of Good Project Management practice (GPM), including developing an understanding of the responsibilities of project leaders, managers, members, and mentors, team interactions, required documents, study site management involvement, and the project life cycle.

Learning Outcomes

  • Compare the key components in Good Project Management Practices, including responsibilities of project leaders, managers and project team members.
  • Examine the project activities involved in the conduct of clinical trials.
  • Evaluate the regulatory foundations for all components of the clinical operation process.
  • Test the key project life cycle components to clinical trials.
  • Write the project management requirements for, and activities involved in closing-out a completed (or terminated) clinical trial.
  • Assemble a biomedical product clinical trial.