Prereq: BT 560 (GCP), BT 575 (Design & Conduct of Clin Trials) or consent of program director. This course integrates a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research. Through lectures, case studies and discussions, students examine the concepts and applied techniques for cost estimation, budgeting, allocation of resources, risk management and quality assurance for clinical research projects. Project management principles and methodologies are discussed with a special focus on planning, controlling, and coordinating individual and group efforts.