This course addresses critical elements in the effective planning and management of clinical trials. Exercises and case studies illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic development plans, team and site performance problems, and post-marketing studies are also discussed. This course will benefit clinical research professionals with a solid foundation in drug development, GCP and monitoring who are beginning to manage clinical trials.
Skills needed: "Good Clinical Practice" or "Good Manufacturing Practice," and "Drug Development Process." A basic understanding of human subjects protection in clinical research is preferred.
Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.