BMI 544 Introduction to Clinical Trials ll

Fall - 3 credits

This course will provide practical experience and training in clinical trial research. The course will focus on the design, implementation, and conduct of clinical trials. Topics include: regulatory requirements for cinical trials; data collection strategies, data quality and management; budget development and justification; federal, institutional, and sponsor-defined requirements; establishment of research infrastructures for safety and success; preparation of investigator-INDs; investigator responsibilities in Phase l-IV trials. Development of data collection and data management systems and a budget for the protocol developed in 541 are require components of this course.