BMI 544 Introduction to Clinical Trials ll
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.